FDA letters by response type
Approval Letter FDA Letters
Application is approved as submitted. Browse source-linked approval letter records with structured metadata, regulatory context, and document-level summaries.
| Letter | Type | Date | Agency / Product | Status |
|---|---|---|---|---|
Approval Letter GENENTECH INC (Oct 5, 2026) FDA posted an approval letter for ROZLYTREK on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212725, NDA 218550 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROZLYTREK | Closed |
Approval Letter EVER VALINJECT (Oct 5, 2026) FDA posted an approval letter for NDA 219617 on 2026-10-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219617 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NDA 219617 | Closed |
Approval Letter AGL WELDING SUPPLY CO INC DBA AGL GAS TECHNOLOGIES (Oct 2, 2026) FDA posted an approval letter for CARBON DIOXIDE, USP on 2026-10-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 222000 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CARBON DIOXIDE, USP | Closed |
Approval Letter MSD MERCK CO (Oct 1, 2026) FDA posted an approval letter for PIFELTRO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PIFELTRO | Closed |
Approval Letter BRISTOL (Oct 1, 2026) FDA posted an approval letter for CAMZYOS on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214998 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAMZYOS | Closed |
Approval Letter B BRAUN (Oct 1, 2026) FDA posted an approval letter for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019631 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER / DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER / DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | Closed |
Approval Letter JAZZ (Oct 1, 2026) FDA posted an approval letter for ZEPZELCA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPZELCA | Closed |
Approval Letter CHEPLAPHARM (Oct 1, 2026) FDA posted an approval letter for XENICAL on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020766 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XENICAL | Closed |
Approval Letter CELLTRION INC (Oct 1, 2026) FDA posted an approval letter for AVTOZMA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVTOZMA | Closed |
Approval Letter MSD MERCK CO (Oct 1, 2026) FDA posted an approval letter for DELSTRIGO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210807 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DELSTRIGO | Closed |
Approval Letter CELLTRION INC (Oct 1, 2026) FDA posted an approval letter for EYDENZELT on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761377 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EYDENZELT | Closed |
Approval Letter LEADIANT BIOSCI INC (Sep 30, 2026) FDA posted an approval letter for MATULANE on 2026-09-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016785 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MATULANE | Closed |
Approval Letter CELLTRION INC (Sep 30, 2026) FDA posted an approval letter for AVTOZMA on 2026-09-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761498 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVTOZMA | Closed |
Approval Letter AVYXA HOLDINGS (Sep 29, 2026) FDA posted an approval letter for BENDAMUSTINE HYDROCHLORIDE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219014 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BENDAMUSTINE HYDROCHLORIDE | Closed |
Approval Letter TEVA PHARMACEUTICALS, INC. (Sep 29, 2026) FDA posted an approval letter for DEGEVMA on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761481 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEGEVMA | Closed |
Approval Letter ELI LILLY AND CO (Sep 29, 2026) FDA posted an approval letter for OLUMIANT on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OLUMIANT | Closed |
Approval Letter EMERGE BIOSCIENCE PTE LTD (Sep 29, 2026) FDA posted an approval letter for YUSIMRY on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761216 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YUSIMRY | Closed |
Approval Letter AZURITY PHARMACEUTICALS INC (Sep 29, 2026) FDA posted an approval letter for NDA 221109 on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221109 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NDA 221109 | Closed |
Approval Letter BAYER HEALTHCARE LLC (Sep 29, 2026) FDA posted an approval letter for CLARITIN, CLARITIN HIVES RELIEF on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019658 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLARITIN / CLARITIN HIVES RELIEF | Closed |
Approval Letter PFIZER INC (Sep 29, 2026) FDA posted an approval letter for RUXIENCE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761103 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RUXIENCE | Closed |
Approval Letter RARE THYROID THERAPEUTICS INTERNATIONAL AB (Sep 29, 2026) FDA posted an approval letter for EMCITATE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220963 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EMCITATE | Closed |
Approval Letter ABBVIE INC (Sep 29, 2026) FDA posted an approval letter for JUVMO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220415 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JUVMO | Closed |
Approval Letter AMGEN INC (Sep 29, 2026) FDA posted an approval letter for RIABNI on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761140 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIABNI | Closed |
Approval Letter INCYTE CORP (Sep 29, 2026) FDA posted an approval letter for ATEBRIOZ on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221198 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ATEBRIOZ | Closed |
Approval Letter ADVENTAPHARMA DWC LLC (Sep 29, 2026) FDA posted an approval letter for ZUEINO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218379 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZUEINO | Closed |
Approval Letter PLANO PHARMS (Sep 29, 2026) FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022485 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN SODIUM CHLORIDE | Closed |
Approval Letter GENENTECH (Sep 29, 2026) FDA posted an approval letter for GAZYVA on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125486 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GAZYVA | Closed |
Approval Letter KENVUE BRANDS (Sep 29, 2026) FDA posted an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF | Closed |
Approval Letter MERCK SHARP DOHME (Sep 28, 2026) FDA posted an approval letter for WELIREG on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WELIREG | Closed |
Approval Letter WAYLIS THERAP (Sep 28, 2026) FDA posted an approval letter for VALIUM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 013263 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VALIUM | Closed |
Approval Letter AGIOS PHARMS INC (Sep 28, 2026) FDA posted an approval letter for PYRUKYND, AQVESME on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PYRUKYND / AQVESME | Closed |
Approval Letter EISAI INC (Sep 28, 2026) FDA posted an approval letter for LENVIMA on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206947 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LENVIMA | Closed |
Approval Letter BAXTER HLTHCARE CORP (Sep 28, 2026) FDA posted an approval letter for DAPZURA RT, DAPTOMYCIN IN 0.9% SODIUM CHLORIDE on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213645 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DAPZURA RT / DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | Closed |
Approval Letter IRONSHORE PHARMS (Sep 28, 2026) FDA posted an approval letter for JORNAY PM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209311 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JORNAY PM | Closed |
Approval Letter ELEVAR THERAPEUTICS INC (Sep 25, 2026) FDA posted an approval letter for LYRFIGTU on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220425 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LYRFIGTU | Closed |
Approval Letter APOTEX (Sep 25, 2026) FDA posted an approval letter for PAXIL, PAXIL CR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020031, NDA 020710, NDA 020936 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PAXIL / PAXIL CR | Closed |
Approval Letter HORIZON THERAPEUTICS IRELAND (Sep 25, 2026) FDA posted an approval letter for TEPEZZA on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761143 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEPEZZA | Closed |
Approval Letter ASTRAZENECA (Sep 25, 2026) FDA posted an approval letter for CRESTOR on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CRESTOR | Closed |
Approval Letter ELI LILLY AND CO (Sep 25, 2026) FDA posted an approval letter for ONSWIK on 2026-09-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761408 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ONSWIK | Closed |
Approval Letter STRIDES PHARMA INTL (Sep 24, 2026) FDA posted an approval letter for METHOTREXATE SODIUM on 2026-09-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 008085 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA METHOTREXATE SODIUM | Closed |
Approval Letter CARMEL BIOSCIENCES (Sep 23, 2026) FDA posted an approval letter for PREXXARTAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209139 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PREXXARTAN | Closed |
Approval Letter BAYER HEALTHCARE (Sep 23, 2026) FDA posted an approval letter for NUBEQA on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212099 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUBEQA | Closed |
Approval Letter NOVARTIS (Sep 23, 2026) FDA posted an approval letter for SCEMBLIX on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SCEMBLIX | Closed |
Approval Letter ALKERMES INC (Sep 23, 2026) FDA posted an approval letter for LUMRYZ on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214755 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LUMRYZ | Closed |
Approval Letter STERIMAX (Sep 23, 2026) FDA posted an approval letter for CLAFORAN on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050547 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLAFORAN | Closed |
Approval Letter UNITED THERAP (Sep 23, 2026) FDA posted an approval letter for TYVASO DPI on 2026-09-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214324 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYVASO DPI | Closed |
Approval Letter ELI LILLY AND CO (Sep 22, 2026) FDA posted an approval letter for VERZENIO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VERZENIO | Closed |
Approval Letter MERCK SHARP DOHME (Sep 22, 2026) FDA posted an approval letter for WINREVAIR on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WINREVAIR | Closed |
Approval Letter ELI LILLY AND CO (Sep 22, 2026) FDA posted an approval letter for INLURIYO on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218881 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INLURIYO | Closed |
Approval Letter IPSEN (Sep 22, 2026) FDA posted an approval letter for SOHONOS on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215559 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOHONOS | Closed |
Approval Letter INTRABIO (Sep 22, 2026) FDA posted an approval letter for AQNEURSA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219132 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AQNEURSA | Closed |
Approval Letter MAYNE PHARMA (Sep 22, 2026) FDA posted an approval letter for ANNOVERA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209627 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ANNOVERA | Closed |
Approval Letter JANSSEN PHARMS (Sep 21, 2026) FDA posted an approval letter for SPRAVATO on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPRAVATO | Closed |
Approval Letter NUVATION (Sep 21, 2026) FDA posted an approval letter for IBTROZI on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219713 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IBTROZI | Closed |
Approval Letter BAYER HEALTHCARE (Sep 21, 2026) FDA posted an approval letter for AMBELVIST on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219627 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AMBELVIST | Closed |
Approval Letter RIDHISIDHI, PLLC (Sep 21, 2026) FDA posted an approval letter for EMPAGLIFLOZIN on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220758 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EMPAGLIFLOZIN | Closed |
Approval Letter PF PRISM CV (Sep 21, 2026) FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XELJANZ / XELJANZ XR | Closed |
Approval Letter ASTRAZENECA (Sep 21, 2026) FDA posted an approval letter for TRUQAP on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRUQAP | Closed |
Approval Letter NOVARTIS (Sep 21, 2026) FDA posted an approval letter for ZORTRESS on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021560 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZORTRESS | Closed |
Approval Letter BAYER HLTHCARE (Sep 21, 2026) FDA posted an approval letter for KERENDIA on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215341 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KERENDIA | Closed |
Approval Letter OTSUKA (Sep 16, 2026) FDA posted an approval letter for JYNARQUE on 2026-09-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204441 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JYNARQUE | Closed |
Approval Letter EMERGE BIOSCIENCE PTE. LTD. (Sep 16, 2026) FDA posted an approval letter for GARZULYS on 2026-09-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GARZULYS | Closed |
Approval Letter AMGEN INC (Sep 15, 2026) FDA posted an approval letter for IMDELLTRA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761344 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMDELLTRA | Closed |
Approval Letter GENENTECH INC (Sep 15, 2026) FDA posted an approval letter for EVRYSDI on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213535, NDA 219285 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EVRYSDI | Closed |
Approval Letter TELIX (Sep 15, 2026) FDA posted an approval letter for PIXCLARA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218592 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PIXCLARA | Closed |
Approval Letter ABBVIE (Sep 15, 2026) FDA posted an approval letter for KYBELLA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206333 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KYBELLA | Closed |
Approval Letter CURIUM (Sep 15, 2026) FDA posted an approval letter for BEXLUTRY on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218525 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BEXLUTRY | Closed |
Approval Letter PHARMING (Sep 15, 2026) FDA posted an approval letter for JOENJA on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217759 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JOENJA | Closed |
Approval Letter SCHOLAR ROCK INC (Sep 15, 2026) FDA posted an approval letter for ISEMBYLD on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761463 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ISEMBYLD | Closed |
Approval Letter ASTRAZENECA (Sep 15, 2026) FDA posted an approval letter for TAGRISSO on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208065 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAGRISSO | Closed |
Approval Letter ASCEND THERAPS US (Sep 11, 2026) FDA posted an approval letter for ESTROGEL on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021166 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ESTROGEL | Closed |
Approval Letter ZYDUS LIFESCIENCES (Sep 11, 2026) FDA posted an approval letter for ZITUVIMET XR on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITUVIMET XR | Closed |
Approval Letter ELI LILLY AND CO (Sep 10, 2026) FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN | Closed |
Approval Letter BIOFRONTERA (Sep 10, 2026) FDA posted an approval letter for AMELUZ on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208081 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AMELUZ | Closed |
Approval Letter BAYER HEALTHCARE (Sep 10, 2026) FDA posted an approval letter for HYRNUO on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219972 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HYRNUO | Closed |
Approval Letter ASTRAZENECA (Sep 8, 2026) FDA posted an approval letter for ETCAMAH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220359 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ETCAMAH | Closed |
Approval Letter NOVO (Sep 8, 2026) FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Sep 8, 2026) FDA posted an approval letter for BYOOVIZ on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BYOOVIZ | Closed |
Approval Letter NOVO (Sep 8, 2026) FDA posted an approval letter for OZEMPIC on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OZEMPIC | Closed |
Approval Letter MSN (Sep 4, 2026) FDA posted an approval letter for POMALIDOMIDE on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210245 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POMALIDOMIDE | Closed |
Approval Letter CHEPLAPHARM (Sep 4, 2026) FDA posted an approval letter for ETOPOPHOS PRESERVATIVE FREE on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020457 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ETOPOPHOS PRESERVATIVE FREE | Closed |
Approval Letter PFIZER (Sep 4, 2026) FDA posted an approval letter for CIBINQO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CIBINQO | Closed |
Approval Letter PRECISION DOSE INC (Sep 4, 2026) FDA posted an approval letter for ALENDRONATE SODIUM on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214523 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALENDRONATE SODIUM | Closed |
Approval Letter BRISTOL-MYERS (Sep 4, 2026) FDA posted an approval letter for THALOMID on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA THALOMID | Closed |
Approval Letter AADI (Sep 4, 2026) FDA posted an approval letter for FYARRO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213312 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FYARRO | Closed |
Approval Letter CELLTRION INC (Sep 4, 2026) FDA posted an approval letter for AVTOZMA on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761498 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVTOZMA | Closed |
Approval Letter CELLTRION INC (Sep 4, 2026) FDA posted an approval letter for AVTOZMA on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVTOZMA | Closed |
Approval Letter IONIS PHARMS INC (Sep 4, 2026) FDA posted an approval letter for ZANVASTRO on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220210 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZANVASTRO | Closed |
Approval Letter HANDA ONCOL (Sep 3, 2026) FDA posted an approval letter for OMCAZIO on 2026-09-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220613 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OMCAZIO | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Sep 3, 2026) FDA posted an approval letter for DUPIXENT on 2026-09-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUPIXENT | Closed |
Approval Letter EMD SERONO INC (Sep 2, 2026) FDA posted an approval letter for BAVENCIO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761049 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BAVENCIO | Closed |
Approval Letter AKESO BIOPHARMA (Sep 2, 2026) FDA posted an approval letter for PENPULIMAB-KCQX on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761258 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PENPULIMAB-KCQX | Closed |
Approval Letter BAXTER HLTHCARE CORP (Sep 2, 2026) FDA posted an approval letter for CEFAZOLIN IN DEXTROSE on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207131 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEFAZOLIN IN DEXTROSE | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Sep 2, 2026) FDA posted an approval letter for LIBTAYO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761097 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LIBTAYO | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Sep 2, 2026) FDA posted an approval letter for YERVOY on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125377 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YERVOY | Closed |
Approval Letter CHATTEM SANOFI (Sep 2, 2026) FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XYZAL ALLERGY 24HR | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Sep 2, 2026) FDA posted an approval letter for BYOOVIZ on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BYOOVIZ | Closed |
Approval Letter ASTRAZENECA UK LTD (Sep 2, 2026) FDA posted an approval letter for IMFINZI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMFINZI | Closed |
Approval Letter BRISTOL (Sep 2, 2026) FDA posted an approval letter for KRAZATI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KRAZATI | Closed |
Approval Letter XTM CONSULTING (Sep 2, 2026) FDA posted an approval letter for LOPRESSOR on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218698 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LOPRESSOR | Closed |
Approval Letter PHARMAESSENTIA CORP (Sep 2, 2026) FDA posted an approval letter for BESREMI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BESREMI | Closed |
Approval Letter COHERUS BIOSCIENCES INC (Sep 2, 2026) FDA posted an approval letter for LOQTORZI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761240 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LOQTORZI | Closed |
Approval Letter GILEAD SCIENCES INC (Sep 2, 2026) FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) | Closed |
Approval Letter PFIZER (Sep 2, 2026) FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN HYDROCHLORIDE | Closed |
Approval Letter BAXTER HLTHCARE (Sep 2, 2026) FDA posted an approval letter for BACTOCILL IN PLASTIC CONTAINER on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050640 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BACTOCILL IN PLASTIC CONTAINER | Closed |
Approval Letter CHECKPOINT THERAPEUTICS INC (Sep 2, 2026) FDA posted an approval letter for UNLOXCYT on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761297 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA UNLOXCYT | Closed |
Approval Letter ASTRAZENECA AB (Sep 2, 2026) FDA posted an approval letter for IMJUDO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761289 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMJUDO | Closed |
Approval Letter ELI LILLY AND CO (Sep 1, 2026) FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866, NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN | Closed |
Approval Letter TAKEDA PHARMS AM (Sep 1, 2026) FDA posted an approval letter for MIMRYLO on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220605 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MIMRYLO | Closed |
Approval Letter JANSSEN BIOTECH (Sep 1, 2026) FDA posted an approval letter for STELARA on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STELARA | Closed |
Approval Letter EMERGE BIOSCIENCE PTE LTD (Sep 1, 2026) FDA posted an approval letter for YUSIMRY on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761216 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YUSIMRY | Closed |
Approval Letter MILLA PHARMS (Sep 1, 2026) FDA posted an approval letter for CALCIUM GLUCONATE IN SODIUM CHLORIDE on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219037 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CALCIUM GLUCONATE IN SODIUM CHLORIDE | Closed |
Approval Letter ETON (Sep 1, 2026) FDA posted an approval letter for HEMANGEOL on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205410 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HEMANGEOL | Closed |
Approval Letter PHARMAESSENTIA CORP (Sep 1, 2026) FDA posted an approval letter for BESREMI on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BESREMI | Closed |
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026) FDA posted an approval letter for BIXLENVO on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221104 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIXLENVO | Closed |
Approval Letter SUN PHARM (Aug 28, 2026) FDA posted an approval letter for VOBRIG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213225 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VOBRIG | Closed |
Approval Letter REVOLUTION MEDICINES (Aug 28, 2026) FDA posted an approval letter for RASONQUE on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220910 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RASONQUE | Closed |
Approval Letter PRIOVANT THERAP (Aug 28, 2026) FDA posted an approval letter for LISRAYA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220106 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LISRAYA | Closed |
Approval Letter JANSSEN BIOTECH (Aug 28, 2026) FDA posted an approval letter for IMAAVY on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761430 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMAAVY | Closed |
Approval Letter NOVO (Aug 28, 2026) FDA posted an approval letter for OZEMPIC on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OZEMPIC | Closed |
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026) FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) | Closed |
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026) FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUNLENCA | Closed |
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026) FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215973 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUNLENCA | Closed |
Approval Letter ELI LILLY AND CO (Aug 28, 2026) FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN | Closed |
Approval Letter CURIUM (Aug 28, 2026) FDA posted an approval letter for ULTRATAG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019981 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ULTRATAG | Closed |
Approval Letter LINDE GAS EQUIP (Aug 28, 2026) FDA posted an approval letter for NITROUS OXIDE, USP on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221892 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NITROUS OXIDE, USP | Closed |
Approval Letter TAKEDA PHARMS USA (Aug 28, 2026) FDA posted an approval letter for GATTEX KIT on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203441 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GATTEX KIT | Closed |
Approval Letter JAZZ PHARMS (Aug 27, 2026) FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIIHERA | Closed |
Approval Letter JAZZ PHARMS (Aug 27, 2026) FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIIHERA | Closed |
Approval Letter BEIGENE (Aug 27, 2026) FDA posted an approval letter for TEVIMBRA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761232 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEVIMBRA | Closed |
Approval Letter VIIV HLTHCARE (Aug 27, 2026) FDA posted an approval letter for TIVICAY, TIVICAY PD on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204790, NDA 213983 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TIVICAY / TIVICAY PD | Closed |
Approval Letter INFORLIFE (Aug 26, 2026) FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-08-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215700 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | Closed |
Approval Letter GLAXOSMITHKLINE LLC (Aug 25, 2026) FDA posted an approval letter for BENLYSTA on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761043, BLA 125370 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BENLYSTA | Closed |
Approval Letter VANTIVE US HLTHCARE (Aug 24, 2026) FDA posted an approval letter for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017512 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER / DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER / DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | Closed |
Approval Letter NOVARTIS (Aug 24, 2026) FDA posted an approval letter for SCEMBLIX on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SCEMBLIX | Closed |
Approval Letter BIOCON BIOLOGICS INC (Aug 22, 2026) FDA posted an approval letter for YESAFILI on 2026-08-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761274 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YESAFILI | Closed |
Approval Letter SPRINGWORKS (Aug 21, 2026) FDA posted an approval letter for OGSIVEO on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OGSIVEO | Closed |
Approval Letter DYAX CORP. (Aug 21, 2026) FDA posted an approval letter for TAKHZYRO on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761090 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAKHZYRO | Closed |
Approval Letter HOFFMANN LA ROCHE (Aug 21, 2026) FDA posted an approval letter for ZELBORAF on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202429 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZELBORAF | Closed |
Approval Letter GENENTECH INC (Aug 21, 2026) FDA posted an approval letter for COTELLIC on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206192 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COTELLIC | Closed |
Approval Letter APELLIS PHARMS (Aug 21, 2026) FDA posted an approval letter for EMPAVELI on 2026-08-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215014 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EMPAVELI | Closed |
Approval Letter PFIZER (Aug 20, 2026) FDA posted an approval letter for ZAVZPRET on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216386 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZAVZPRET | Closed |
Approval Letter REGENERON PHARMACEUTICALS, INC (Aug 20, 2026) FDA posted an approval letter for PASATRU on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761508 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PASATRU | Closed |
Approval Letter FRESENIUS KABI USA (Aug 20, 2026) FDA posted an approval letter for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017584 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | Closed |
Approval Letter ALMATICA (Aug 20, 2026) FDA posted an approval letter for DULOXETINE HYDROCHLORIDE on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219131 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DULOXETINE HYDROCHLORIDE | Closed |
Approval Letter ORGANON (Aug 20, 2026) FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMPLANON / NEXPLANON | Closed |
Approval Letter NOVARTIS (Aug 20, 2026) FDA posted an approval letter for LEQVIO on 2026-08-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEQVIO | Closed |
Approval Letter SANOFI AVENTIS US (Aug 19, 2026) FDA posted an approval letter for AVAPRO on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVAPRO | Closed |
Approval Letter HIKMA (Aug 19, 2026) FDA posted an approval letter for TYZAVAN on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211962 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYZAVAN | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Aug 19, 2026) FDA posted an approval letter for BARACLUDE on 2026-08-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021797, NDA 021798 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BARACLUDE | Closed |
Approval Letter INDIVIOR (Aug 18, 2026) FDA posted an approval letter for SUBOXONE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022410 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUBOXONE | Closed |
Approval Letter IPSEN (Aug 18, 2026) FDA posted an approval letter for IQIRVO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218860 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IQIRVO | Closed |
Approval Letter BAXTER HLTHCARE CORP (Aug 18, 2026) FDA posted an approval letter for SODIUM BICARBONATE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218524 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SODIUM BICARBONATE | Closed |
Approval Letter HOFFMANN-LA ROCHE (Aug 18, 2026) FDA posted an approval letter for ALECENSA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALECENSA | Closed |
Approval Letter HORIZON PHARMA (Aug 18, 2026) FDA posted an approval letter for KRYSTEXXA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125293 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KRYSTEXXA | Closed |
Approval Letter LIB THERAPEUTICS, INC. (Aug 18, 2026) FDA posted an approval letter for LEROCHOL on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761427 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEROCHOL | Closed |
Approval Letter EDENBRIDGE PHARMS (Aug 18, 2026) FDA posted an approval letter for ZUBSOLV on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204242 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZUBSOLV | Closed |
Approval Letter BOEHRINGER INGELHEIM (Aug 18, 2026) FDA posted an approval letter for JASCAYD on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JASCAYD | Closed |
Approval Letter ASTRAZENECA AB (Aug 18, 2026) FDA posted an approval letter for SAPHNELO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761123 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SAPHNELO | Closed |
Approval Letter BIOCON BIOLOGICS INC (Aug 18, 2026) FDA posted an approval letter for YESINTEK on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761406 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YESINTEK | Closed |
Approval Letter AM REGENT (Aug 17, 2026) FDA posted an approval letter for INJECTAFER on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203565 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INJECTAFER | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Aug 17, 2026) FDA posted an approval letter for ZENBEXUS on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221075 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZENBEXUS | Closed |
Approval Letter CERVEAU LANTHEUS (Aug 17, 2026) FDA posted an approval letter for TAUKLARIFY on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220496 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAUKLARIFY | Closed |
Approval Letter GILEAD SCIENCES INC (Aug 17, 2026) FDA posted an approval letter for BIKTARVY on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210251 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIKTARVY | Closed |
Approval Letter AMARIN PHARMS (Aug 17, 2026) FDA posted an approval letter for VASCEPA on 2026-08-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202057 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VASCEPA | Closed |
Approval Letter SANTARUS INC (Aug 14, 2026) FDA posted an approval letter for GLUMETZA on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021748 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GLUMETZA | Closed |
Approval Letter SUN PHARM (Aug 14, 2026) FDA posted an approval letter for RIOMET ER on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212595 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIOMET ER | Closed |
Approval Letter ASTRAZENECA AB (Aug 14, 2026) FDA posted an approval letter for XIGDUO XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205649 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XIGDUO XR | Closed |
Approval Letter SUN PHARM INDS INC (Aug 14, 2026) FDA posted an approval letter for ABSORICA, ABSORICA LD on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABSORICA / ABSORICA LD | Closed |
Approval Letter TAKEDA PHARMS USA (Aug 14, 2026) FDA posted an approval letter for KAZANO on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203414 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KAZANO | Closed |
Approval Letter ASTRAZENECA AB (Aug 14, 2026) FDA posted an approval letter for KOMBIGLYZE XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200678 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KOMBIGLYZE XR | Closed |
Approval Letter BOEHRINGER INGELHEIM (Aug 14, 2026) FDA posted an approval letter for JENTADUETO, SYNJARDY, JENTADUETO XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201281, NDA 206111, NDA 208026, NDA 208658, NDA 212614 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JENTADUETO / SYNJARDY / JENTADUETO XR | Closed |
Approval Letter ZYDUS LIFESCIENCES (Aug 14, 2026) FDA posted an approval letter for ZITUVIMET, ZITUVIMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216743, NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITUVIMET / ZITUVIMET XR | Closed |
Approval Letter ANDRX LABS LLC (Aug 14, 2026) FDA posted an approval letter for FORTAMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021574 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FORTAMET | Closed |
Approval Letter JANSSEN PHARMS (Aug 14, 2026) FDA posted an approval letter for INVOKAMET, INVOKAMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204353, NDA 205879 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INVOKAMET / INVOKAMET XR | Closed |
Approval Letter MSD SUB MERCK (Aug 14, 2026) FDA posted an approval letter for JANUMET, JANUMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022044, NDA 202270 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JANUMET / JANUMET XR | Closed |
Approval Letter MSD SUB MERCK (Aug 14, 2026) FDA posted an approval letter for SEGLUROMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SEGLUROMET | Closed |
Approval Letter TAKEDA PHARMS USA (Aug 14, 2026) FDA posted an approval letter for ACTOPLUS MET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021842 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ACTOPLUS MET | Closed |
Approval Letter SANDOZ (Aug 13, 2026) FDA posted an approval letter for DUREZOL on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022212 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUREZOL | Closed |
Approval Letter DELCATH SYSTEMS INC (Aug 13, 2026) FDA posted an approval letter for HEPZATO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HEPZATO | Closed |
Approval Letter OXFORD PHARMS (Aug 13, 2026) FDA posted an approval letter for RIMACTANE on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050429 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIMACTANE | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Aug 13, 2026) FDA posted an approval letter for OPDIVO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPDIVO | Closed |
Approval Letter MERCK SHARP DOHME (Aug 13, 2026) FDA posted an approval letter for WINREVAIR on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WINREVAIR | Closed |
Approval Letter GENUS (Aug 11, 2026) FDA posted an approval letter for POTASSIUM CHLORIDE, POKONZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208019 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POTASSIUM CHLORIDE / POKONZA | Closed |
Approval Letter AGIOS PHARMS INC (Aug 11, 2026) FDA posted an approval letter for PYRUKYND, AQVESME on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PYRUKYND / AQVESME | Closed |
Approval Letter GENENTECH INC (Aug 11, 2026) FDA posted an approval letter for XOFLUZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210854 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XOFLUZA | Closed |
Approval Letter HQ SPCLT PHARMA (Aug 11, 2026) FDA posted an approval letter for MEROPENEM on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215212 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MEROPENEM | Closed |
Approval Letter PRIMUS PHARMS (Aug 11, 2026) FDA posted an approval letter for SERNIVO on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208079 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SERNIVO | Closed |
Approval Letter IDORSIA (Aug 10, 2026) FDA posted an approval letter for TRYVIO on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217686 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRYVIO | Closed |
Approval Letter LEXICON PHARMS INC (Aug 10, 2026) FDA posted an approval letter for INPEFA on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216203 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INPEFA | Closed |
Approval Letter GENENTECH (Aug 10, 2026) FDA posted an approval letter for XOLAIR on 2026-08-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103976 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XOLAIR | Closed |
Approval Letter BAYER HLTHCARE (Aug 6, 2026) FDA posted an approval letter for ADEMPAS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204819 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADEMPAS | Closed |
Approval Letter TAKEDA PHARMS USA (Aug 6, 2026) FDA posted an approval letter for ORZEYFUL on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220860 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ORZEYFUL | Closed |
Approval Letter RADIUS (Aug 6, 2026) FDA posted an approval letter for TYMLOS on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208743 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYMLOS | Closed |
Approval Letter PRAGMA (Aug 6, 2026) FDA posted an approval letter for KEFLEX on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050405 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEFLEX | Closed |
Approval Letter ALVOGEN (Aug 6, 2026) FDA posted an approval letter for BONSITY on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211939 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BONSITY | Closed |
Approval Letter ASCENDIS PHARMA BONE (Aug 6, 2026) FDA posted an approval letter for YORVIPATH on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216490 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YORVIPATH | Closed |
Approval Letter ALMAJECT (Aug 6, 2026) FDA posted an approval letter for TERIPARATIDE on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218771 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TERIPARATIDE | Closed |
Approval Letter AMGEN (Aug 6, 2026) FDA posted an approval letter for NEULASTA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125031 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEULASTA | Closed |
Approval Letter CELLTRION (Aug 6, 2026) FDA posted an approval letter for YUFLYMA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761219 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YUFLYMA | Closed |
Approval Letter LILLY (Aug 6, 2026) FDA posted an approval letter for FORTEO on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021318 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FORTEO | Closed |
Approval Letter BOEHRINGER INGELHEIM (Aug 4, 2026) FDA posted an approval letter for HERNEXEOS on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HERNEXEOS | Closed |
Approval Letter MERCK SHARP DOHME (Aug 4, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter NOVARTIS (Aug 4, 2026) FDA posted an approval letter for PLUVICTO on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215833 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PLUVICTO | Closed |
Approval Letter DR REDDYS LABS SA (Aug 4, 2026) FDA posted an approval letter for ZIMRIXBY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761376 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIMRIXBY | Closed |
Approval Letter BOEHRINGER INGELHEIM (Aug 4, 2026) FDA posted an approval letter for HERNEXEOS on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HERNEXEOS | Closed |
Approval Letter ACCORD HLTHCARE (Aug 4, 2026) FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN SODIUM CHLORIDE | Closed |
Approval Letter RENGENERON PHARMACEUTICALS, INC. (Aug 4, 2026) FDA posted an approval letter for LYNOZYFIC on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761400 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LYNOZYFIC | Closed |
Approval Letter SCPHARMACEUTICALS (Aug 3, 2026) FDA posted an approval letter for FUROSCIX, FUROSCIX READYFLOW (AUTOINJECTOR) on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209988 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FUROSCIX / FUROSCIX READYFLOW (AUTOINJECTOR) | Closed |
Approval Letter ROCHE PALO (Aug 3, 2026) FDA posted an approval letter for CELLCEPT on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050722, NDA 050723, NDA 050758, NDA 050759 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CELLCEPT | Closed |
Approval Letter CMP DEV LLC (Jul 30, 2026) FDA posted an approval letter for QLONILIK on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221094 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QLONILIK | Closed |
Approval Letter NOBLE GAS SOLUTIONS INC. (Jul 30, 2026) FDA posted an approval letter for AIR on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221805 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AIR | Closed |
Approval Letter NOVARTIS (Jul 30, 2026) FDA posted an approval letter for MYFORTIC on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050791 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MYFORTIC | Closed |
Approval Letter AZURITY (Jul 30, 2026) FDA posted an approval letter for MYHIBBIN on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216482 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MYHIBBIN | Closed |
Approval Letter GILEAD SCIENCES INC (Jul 30, 2026) FDA posted an approval letter for VEKLURY on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214787 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VEKLURY | Closed |
Approval Letter FRESENIUS KABI USA (Jul 30, 2026) FDA posted an approval letter for GLYCOPHOS on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220381 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GLYCOPHOS | Closed |
Approval Letter VIATRIS SPECIALTY (Jul 30, 2026) FDA posted an approval letter for GWYN LO on 2026-07-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219990 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GWYN LO | Closed |
Approval Letter BAYER HLTHCARE (Jul 29, 2026) FDA posted an approval letter for GADAVIST on 2026-07-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201277 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GADAVIST | Closed |
Approval Letter VANDA PHARMS INC (Jul 29, 2026) FDA posted an approval letter for HETLIOZ on 2026-07-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205677 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HETLIOZ | Closed |
Approval Letter SANOFI AVENTIS US (Jul 28, 2026) FDA posted an approval letter for AVAPRO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVAPRO | Closed |
Approval Letter EMERGE BIOSCIENCE PTE. LTD. (Jul 28, 2026) FDA posted an approval letter for GARZULYS on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GARZULYS | Closed |
Approval Letter OUTLOOK THERAPEUTICS, INC. (Jul 28, 2026) FDA posted an approval letter for LYTENAVA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761320 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LYTENAVA | Closed |
Approval Letter XTTRIUM (Jul 28, 2026) FDA posted an approval letter for DYNA-HEX 2 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DYNA-HEX 2 | Closed |
Approval Letter XTTRIUM (Jul 28, 2026) FDA posted an approval letter for DYNA-HEX 4 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DYNA-HEX 4 | Closed |
Approval Letter MADRIGAL (Jul 28, 2026) FDA posted an approval letter for REZDIFFRA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217785 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REZDIFFRA | Closed |
Approval Letter GLAXOSMITHKLINE (Jul 28, 2026) FDA posted an approval letter for BREXAFEMME on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214900 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BREXAFEMME | Closed |
Approval Letter OTSUKA PHARMACEUTICAL CO LTD (Jul 28, 2026) FDA posted an approval letter for SIMTRIYO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218145 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SIMTRIYO | Closed |
Approval Letter MERIDIAN BIOSCIENCE (Jul 28, 2026) FDA posted an approval letter for IDKIT:HP on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021314 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDKIT:HP | Closed |
Approval Letter TEVA BRANDED PHARM (Jul 28, 2026) FDA posted an approval letter for ZIAC on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIAC | Closed |
Approval Letter ASTELLAS (Jul 28, 2026) FDA posted an approval letter for XTANDI on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203415, NDA 213674 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XTANDI | Closed |
Approval Letter ABBVIE (Jul 27, 2026) FDA posted an approval letter for NORVIR on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022417, NDA 209512 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NORVIR | Closed |
Approval Letter AETERNA ZENTARIS (Jul 27, 2026) FDA posted an approval letter for MACRILEN on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MACRILEN | Closed |
Approval Letter SANDOZ INC (Jul 27, 2026) FDA posted an approval letter for TYRUKO on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761322 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYRUKO | Closed |
Approval Letter ABBVIE (Jul 27, 2026) FDA posted an approval letter for KALETRA on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021906, NDA 021251 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KALETRA | Closed |
Approval Letter AUROBINDO PHARMA LTD (Jul 24, 2026) FDA posted an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BUPROPION HYDROCHLORIDE | Closed |
Approval Letter NUVALENT (Jul 24, 2026) FDA posted an approval letter for JIDEYTRO on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220185 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JIDEYTRO | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Jul 24, 2026) FDA posted an approval letter for REVLIMID on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REVLIMID | Closed |
Approval Letter KENVUE BRANDS (Jul 24, 2026) FDA posted an approval letter for CHILDREN'S MOTRIN, MOTRIN IB on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020516 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S MOTRIN / MOTRIN IB | Closed |
Approval Letter LANTHEUS (Jul 24, 2026) FDA posted an approval letter for NEURACEQ on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204677 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEURACEQ | Closed |
Approval Letter KENVUE BRANDS (Jul 24, 2026) FDA posted an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYLENOL WITH NAPROXEN | Closed |
Approval Letter ACCORD (Jul 23, 2026) FDA posted an approval letter for CAMCEVI ETM on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219745 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAMCEVI ETM | Closed |
Approval Letter BAUSCH (Jul 23, 2026) FDA posted an approval letter for ACANYA, ONEXTON on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050819 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ACANYA / ONEXTON | Closed |
Approval Letter MYLAN (Jul 22, 2026) FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217769 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FERRIC CARBOXYMALTOSE | Closed |
Approval Letter INCYTE CORP (Jul 22, 2026) FDA posted an approval letter for JAKAFI, JAKAFI XR on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202192, NDA 217180 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JAKAFI / JAKAFI XR | Closed |
Approval Letter HIKMA (Jul 22, 2026) FDA posted an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218016 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOLRIAMFETOL HYDROCHLORIDE | Closed |
Approval Letter ANNORA PHARMA (Jul 22, 2026) FDA posted an approval letter for FOSTAMATINIB DISODIUM on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217329 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOSTAMATINIB DISODIUM | Closed |
Approval Letter LUPIN (Jul 22, 2026) FDA posted an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE | Closed |
Approval Letter SANDOZ (Jul 22, 2026) FDA posted an approval letter for VASOPRESSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VASOPRESSIN | Closed |
Approval Letter AMNEAL (Jul 22, 2026) FDA posted an approval letter for ROMIDEPSIN on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219099 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROMIDEPSIN | Closed |
Approval Letter PAI HOLDINGS (Jul 22, 2026) FDA posted an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219165 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROPRANOLOL HYDROCHLORIDE | Closed |
Approval Letter BRISTOL-MYERS (Jul 22, 2026) FDA posted an approval letter for INREBIC on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INREBIC | Closed |
Approval Letter SOBI (Jul 22, 2026) FDA posted an approval letter for VONJO on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VONJO | Closed |
Approval Letter MYLAN (Jul 22, 2026) FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217076 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FERRIC CARBOXYMALTOSE | Closed |
Approval Letter GLAXOSMITHKLINE (Jul 22, 2026) FDA posted an approval letter for OJJAARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OJJAARA | Closed |
Approval Letter MYLAN LABS LTD (Jul 22, 2026) FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212572 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FERRIC CARBOXYMALTOSE | Closed |
Approval Letter DR REDDYS (Jul 22, 2026) FDA posted an approval letter for VENETOCLAX on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214733 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VENETOCLAX | Closed |
Approval Letter ALKEM LABS LTD (Jul 22, 2026) FDA posted an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218722 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOLRIAMFETOL HYDROCHLORIDE | Closed |
Approval Letter HIKMA (Jul 21, 2026) FDA posted an approval letter for EPINEPHRINE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220562 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPINEPHRINE | Closed |
Approval Letter OWP PHARMS (Jul 21, 2026) FDA posted an approval letter for SUBVENITE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218879 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUBVENITE | Closed |
Approval Letter UMEDICA LABS PVT (Jul 21, 2026) FDA posted an approval letter for ZOLPIDEM TARTRATE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220717 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZOLPIDEM TARTRATE | Closed |
Approval Letter US ANTIBIOTICS (Jul 21, 2026) FDA posted an approval letter for AUGMENTIN '125', AUGMENTIN '250', AUGMENTIN '200' on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050575, NDA 050726, NDA 050785, NDA 050597, NDA 050720, NDA 050755, NDA 050725, NDA 050564 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AUGMENTIN '125' / AUGMENTIN '250' / AUGMENTIN '200' | Closed |
Approval Letter IONETIX (Jul 21, 2026) FDA posted an approval letter for GALLIUM GA 68 GOZETOTIDE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219189 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GALLIUM GA 68 GOZETOTIDE | Closed |
Approval Letter NOVITIUM PHARMA (Jul 21, 2026) FDA posted an approval letter for TRAMADOL HYDROCHLORIDE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219647 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRAMADOL HYDROCHLORIDE | Closed |
Approval Letter PH HEALTH (Jul 21, 2026) FDA posted an approval letter for ADRENALIN on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204640 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADRENALIN | Closed |
Approval Letter SPRINGWORKS (Jul 21, 2026) FDA posted an approval letter for OGSIVEO on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OGSIVEO | Closed |
Approval Letter EISAI INC (Jul 20, 2026) FDA posted an approval letter for LEQEMBI IQLIK on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761375 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEQEMBI IQLIK | Closed |
Approval Letter NOVARTIS (Jul 20, 2026) FDA posted an approval letter for FABHALTA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218276 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FABHALTA | Closed |
Approval Letter RUBICON RESEARCH (Jul 20, 2026) FDA posted an approval letter for BUPRENORPHINE HYDROCHLORIDE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 090279 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BUPRENORPHINE HYDROCHLORIDE | Closed |
Approval Letter FRESENIUS KABI USA (Jul 20, 2026) FDA posted an approval letter for ARGATROBAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201811 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN | Closed |
Approval Letter KENVUE BRANDS (Jul 20, 2026) FDA posted an approval letter for CHILDREN'S ZYRTEC HIVES, CHILDREN'S ZYRTEC ALLERGY on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022155 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ZYRTEC HIVES / CHILDREN'S ZYRTEC ALLERGY | Closed |
Approval Letter AMGEN (Jul 20, 2026) FDA posted an approval letter for NEUPOGEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103353 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEUPOGEN | Closed |
Approval Letter NOVARTIS (Jul 20, 2026) FDA posted an approval letter for GLEEVEC on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GLEEVEC | Closed |
Approval Letter SUN PHARMA GLOBAL (Jul 20, 2026) FDA posted an approval letter for ILUMYA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761067 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ILUMYA | Closed |
Approval Letter RENEW PHARMS (Jul 20, 2026) FDA posted an approval letter for IC-GREEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IC-GREEN | Closed |
Approval Letter PFIZER (Jul 20, 2026) FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050710, NDA 050784, NDA 050711 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITHROMAX | Closed |
Approval Letter PFIZER (Jul 20, 2026) FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITHROMAX | Closed |
Approval Letter PFIZER (Jul 20, 2026) FDA posted an approval letter for ZITHROMAX on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050733 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITHROMAX | Closed |
Approval Letter NOVA LABS LTD (Jul 20, 2026) FDA posted an approval letter for PURIXAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205919 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PURIXAN | Closed |
Approval Letter ELI LILLY AND CO (Jul 20, 2026) FDA posted an approval letter for VERZENIO on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VERZENIO | Closed |
Approval Letter MUNDIPHARMA (Jul 20, 2026) FDA posted an approval letter for REZZAYO on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REZZAYO | Closed |
Approval Letter MEDUNIK (Jul 20, 2026) FDA posted an approval letter for PHEBURANE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216513 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PHEBURANE | Closed |
Approval Letter CENTOCOR ORTHO BIOTECH INC (Jul 16, 2026) FDA posted an approval letter for STELARA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STELARA | Closed |
Approval Letter MSD (Jul 16, 2026) FDA posted an approval letter for LIPFENDRA on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220848 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LIPFENDRA | Closed |
Approval Letter FERRING (Jul 16, 2026) FDA posted an approval letter for ENDOMETRIN on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022057 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENDOMETRIN | Closed |
Approval Letter NOVARTIS (Jul 16, 2026) FDA posted an approval letter for TEGRETOL, TEGRETOL-XR on 2026-07-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016608, NDA 018927, NDA 020234 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEGRETOL / TEGRETOL-XR | Closed |
Approval Letter ELI LILLY AND CO (Jul 15, 2026) FDA posted an approval letter for RETEVMO on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213246, NDA 218160 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RETEVMO | Closed |
Approval Letter EMD SERONO (Jul 15, 2026) FDA posted an approval letter for SEROSTIM, SEROSTIM LQ on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 020604 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SEROSTIM / SEROSTIM LQ | Closed |
Approval Letter CELCUITY (Jul 15, 2026) FDA posted an approval letter for REVTORPYK on 2026-07-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219908 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REVTORPYK | Closed |
Approval Letter PROVEPHARM SAS (Jul 13, 2026) FDA posted an approval letter for ZYOGREEN on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218579 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYOGREEN | Closed |
Approval Letter MERCK SHARP DOHME (Jul 13, 2026) FDA posted an approval letter for KEYTRUDA on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter MAINPOINTE (Jul 13, 2026) FDA posted an approval letter for TUXARIN ER on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206323 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TUXARIN ER | Closed |
Approval Letter MERCK SHARP DOHME (Jul 13, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter SANOFI-AVENTIS U.S. LLC (Jul 13, 2026) FDA posted an approval letter for SARCLISA ESCENA on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761445 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SARCLISA ESCENA | Closed |
Approval Letter NOVEN PHARMS INC (Jul 13, 2026) FDA posted an approval letter for XELSTRYM on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215401 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XELSTRYM | Closed |
Approval Letter ASTELLAS (Jul 13, 2026) FDA posted an approval letter for PADCEV on 2026-07-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761137 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PADCEV | Closed |
Approval Letter VIRIDIAN THERAPEUTICS INC (Jul 10, 2026) FDA posted an approval letter for LUMVOA on 2026-07-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761530 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LUMVOA | Closed |
Approval Letter AMNEAL (Jul 10, 2026) FDA posted an approval letter for SODIUM BICARBONATE on 2026-07-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220790 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SODIUM BICARBONATE | Closed |
Approval Letter MERZ (Jul 8, 2026) FDA posted an approval letter for INBRIJA on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INBRIJA | Closed |
Approval Letter VERA THERAPEUTICS INC. (Jul 8, 2026) FDA posted an approval letter for TRUTAKNA on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761486 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRUTAKNA | Closed |
Approval Letter GLENMARK SPECLT (Jul 8, 2026) FDA posted an approval letter for RYALTRIS on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211746 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYALTRIS | Closed |
Approval Letter JANSSEN PHARMS (Jul 8, 2026) FDA posted an approval letter for SPORANOX on 2026-07-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020083, NDA 020657 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPORANOX | Closed |
Approval Letter FRESENIUS KABI USA (Jul 7, 2026) FDA posted an approval letter for LEVOTHYROXINE SODIUM on 2026-07-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202231 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEVOTHYROXINE SODIUM | Closed |
Approval Letter ORGANON (Jul 7, 2026) FDA posted an approval letter for ELOCON on 2026-07-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019625, NDA 019543, NDA 019796 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELOCON | Closed |
Approval Letter FAMYGEN LIFE SCI (Jul 6, 2026) FDA posted an approval letter for RYZUMVI on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217064 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYZUMVI | Closed |
Approval Letter KENVUE BRANDS (Jul 6, 2026) FDA posted an approval letter for ZYRTEC ALLERGY on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022578 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYRTEC ALLERGY | Closed |
Approval Letter NOVARTIS (Jul 6, 2026) FDA posted an approval letter for KISQALI on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209092 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KISQALI | Closed |
Approval Letter SHIONOGI (Jul 6, 2026) FDA posted an approval letter for FETROJA on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209445 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FETROJA | Closed |
Approval Letter MICRO LABS (Jul 6, 2026) FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIVAROXABAN | Closed |
Approval Letter KENVUE BRANDS (Jul 6, 2026) FDA posted an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYRTEC-D 12 HOUR | Closed |
Approval Letter MANKIND PHARMA (Jul 6, 2026) FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220874 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIVAROXABAN | Closed |
Approval Letter NOVARTIS (Jul 6, 2026) FDA posted an approval letter for KISQALI FEMARA CO-PACK (COPACKAGED) on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209935 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KISQALI FEMARA CO-PACK (COPACKAGED) | Closed |
Approval Letter CELLTRION INC (Jul 2, 2026) FDA posted an approval letter for TRUXIMA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761088 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRUXIMA | Closed |
Approval Letter MDD US (Jul 2, 2026) FDA posted an approval letter for ONAPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ONAPGO | Closed |
Approval Letter VIVUS LLC (Jul 2, 2026) FDA posted an approval letter for QSYMIA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QSYMIA | Closed |
Approval Letter INCYTE CORP (Jul 2, 2026) FDA posted an approval letter for OPZELURA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215309 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPZELURA | Closed |
Approval Letter LILLY (Jul 2, 2026) FDA posted an approval letter for STRATTERA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021411 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STRATTERA | Closed |
Approval Letter NOVARTIS (Jul 2, 2026) FDA posted an approval letter for MAYZENT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209884 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MAYZENT | Closed |
Approval Letter TEVA PHARMS USA (Jul 2, 2026) FDA posted an approval letter for COPAXONE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020622 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COPAXONE | Closed |
Approval Letter DELCATH SYSTEMS INC (Jul 2, 2026) FDA posted an approval letter for HEPZATO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HEPZATO | Closed |
Approval Letter ALEXION PHARM (Jul 2, 2026) FDA posted an approval letter for SOLIRIS on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125166 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOLIRIS | Closed |
Approval Letter LEO PHARMA AS (Jul 2, 2026) FDA posted an approval letter for ANZUPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219155 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ANZUPGO | Closed |
Approval Letter PFIZER (Jul 2, 2026) FDA posted an approval letter for XELJANZ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XELJANZ | Closed |
Approval Letter GENENTECH INC (Jul 2, 2026) FDA posted an approval letter for COLUMVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COLUMVI | Closed |
Approval Letter PF PRISM CV (Jul 2, 2026) FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XELJANZ / XELJANZ XR | Closed |
Approval Letter BRISTOL (Jul 2, 2026) FDA posted an approval letter for SOTYKTU on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOTYKTU | Closed |
Approval Letter RECORDATI RARE (Jul 2, 2026) FDA posted an approval letter for ISTURISA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212801 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ISTURISA | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Jul 2, 2026) FDA posted an approval letter for EPYSQLI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPYSQLI | Closed |
Approval Letter PFIZER (Jul 2, 2026) FDA posted an approval letter for CIBINQO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CIBINQO | Closed |
Approval Letter AMGEN INC (Jul 2, 2026) FDA posted an approval letter for BKEMV on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BKEMV | Closed |
Approval Letter ELI LILLY AND CO (Jul 2, 2026) FDA posted an approval letter for OLUMIANT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OLUMIANT | Closed |
Approval Letter SUN PHARM INDS INC (Jul 2, 2026) FDA posted an approval letter for LEQSELVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217900 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEQSELVI | Closed |
Approval Letter ABBVIE (Jul 2, 2026) FDA posted an approval letter for RINVOQ, RINVOQ LQ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211675, NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RINVOQ / RINVOQ LQ | Closed |
Approval Letter ESJAY PHARMA (Jul 2, 2026) FDA posted an approval letter for PARLODEL on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PARLODEL | Closed |
Approval Letter JANSSEN BIOTECH (Jul 2, 2026) FDA posted an approval letter for ERLEADA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ERLEADA | Closed |
Approval Letter ARCUTIS (Jul 2, 2026) FDA posted an approval letter for ZORYVE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215985 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZORYVE | Closed |
Approval Letter PFIZER (Jul 2, 2026) FDA posted an approval letter for LITFULO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215830 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LITFULO | Closed |
Approval Letter CYCLE (Jul 2, 2026) FDA posted an approval letter for TASCENSO ODT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214962 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TASCENSO ODT | Closed |
Approval Letter DECIPHERA PHARMS (Jun 30, 2026) FDA posted an approval letter for ROMVIMZA on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219304 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROMVIMZA | Closed |
Approval Letter VERITY (Jun 30, 2026) FDA posted an approval letter for TRELSTAR on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020715, NDA 021288, NDA 022437 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRELSTAR | Closed |
Approval Letter ISTX (Jun 30, 2026) FDA posted an approval letter for ZEVTERA on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218275 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEVTERA | Closed |
Approval Letter ABBVIE INC (Jun 30, 2026) FDA posted an approval letter for SKYRIZI on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SKYRIZI | Closed |
Approval Letter SANOFI AVENTIS US (Jun 30, 2026) FDA posted an approval letter for SARCLISA on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761113 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SARCLISA | Closed |
Approval Letter TEVA PHARMS USA (Jun 30, 2026) FDA posted an approval letter for ARGATROBAN IN 0.9% SODIUM CHLORIDE on 2026-06-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206769 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN 0.9% SODIUM CHLORIDE | Closed |
Approval Letter BAXTER HLTHCARE (Jun 29, 2026) FDA posted an approval letter for CEFEPIME IN PLASTIC CONTAINER on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050817 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEFEPIME IN PLASTIC CONTAINER | Closed |
Approval Letter KING PHARMS LLC (Jun 29, 2026) FDA posted an approval letter for BICILLIN L-A, BICILLIN C-R, BICILLIN C-R 900/300 on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050141, NDA 050138 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BICILLIN L-A / BICILLIN C-R / BICILLIN C-R 900/300 | Closed |
Approval Letter MERZ PHARMS (Jun 29, 2026) FDA posted an approval letter for Xeomin on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA Xeomin | Closed |
Approval Letter INSMED INC (Jun 29, 2026) FDA posted an approval letter for ARIKAYCE KIT on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207356 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARIKAYCE KIT | Closed |
Approval Letter KING PHARMS LLC (Jun 29, 2026) FDA posted an approval letter for BICILLIN C-R, BICILLIN C-R 900/300, BICILLIN L-A on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050138, NDA 050141 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BICILLIN C-R / BICILLIN C-R 900/300 / BICILLIN L-A | Closed |
Approval Letter HALEON US HOLDINGS (Jun 29, 2026) FDA posted an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED | Closed |
Approval Letter PHARMAESSENTIA CORP (Jun 29, 2026) FDA posted an approval letter for BESREMI on 2026-06-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BESREMI | Closed |
Approval Letter STEMLINE THERAP (Jun 26, 2026) FDA posted an approval letter for ORSERDU on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217639 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ORSERDU | Closed |
Approval Letter PFIZER (Jun 26, 2026) FDA posted an approval letter for IBRANCE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212436 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IBRANCE | Closed |
Approval Letter PFIZER (Jun 26, 2026) FDA posted an approval letter for IBRANCE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207103 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IBRANCE | Closed |
Approval Letter MERCK SHARP DOHME (Jun 26, 2026) FDA posted an approval letter for KEYTRUDA on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter IMMUNOMEDICS INC (Jun 26, 2026) FDA posted an approval letter for TRODELVY on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRODELVY | Closed |
Approval Letter JANSSEN PHARMS (Jun 26, 2026) FDA posted an approval letter for SPRAVATO on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPRAVATO | Closed |
Approval Letter MERCK SHARP DOHME (Jun 26, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter IMMUNOMEDICS INC (Jun 26, 2026) FDA posted an approval letter for TRODELVY on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRODELVY | Closed |
Approval Letter IONIS PHARMS INC (Jun 26, 2026) FDA posted an approval letter for TRYNGOLZA (AUTOINJECTOR) on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218614 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRYNGOLZA (AUTOINJECTOR) | Closed |
Approval Letter MERCK SHARP DOHME (Jun 26, 2026) FDA posted an approval letter for KEYTRUDA on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Jun 26, 2026) FDA posted an approval letter for ELIQUIS, ELIQUIS SPRINKLE on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202155, NDA 220073 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELIQUIS / ELIQUIS SPRINKLE | Closed |
Approval Letter AVYXA HOLDINGS (Jun 26, 2026) FDA posted an approval letter for NAVITRUX on 2026-06-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220436 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NAVITRUX | Closed |
Approval Letter AMGEN (Jun 24, 2026) FDA posted an approval letter for PROLIA, XGEVA on 2026-06-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROLIA / XGEVA | Closed |
Approval Letter AMGEN (Jun 24, 2026) FDA posted an approval letter for PROLIA, XGEVA on 2026-06-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROLIA / XGEVA | Closed |
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026) FDA posted an approval letter for XTAMPZA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208090 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XTAMPZA ER | Closed |
Approval Letter ZEALAND PHARMA (Jun 23, 2026) FDA posted an approval letter for ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR) on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214231 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEGALOGUE / ZEGALOGUE (AUTOINJECTOR) | Closed |
Approval Letter KNOA PHARMA (Jun 23, 2026) FDA posted an approval letter for MS CONTIN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019516 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MS CONTIN | Closed |
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026) FDA posted an approval letter for NUCYNTA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203794 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUCYNTA | Closed |
Approval Letter RHODES PHARMS (Jun 23, 2026) FDA posted an approval letter for DILAUDID on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019891, NDA 019892 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DILAUDID | Closed |
Approval Letter LAVIPHARM (Jun 23, 2026) FDA posted an approval letter for CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018891 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CATAPRES-TTS-1 / CATAPRES-TTS-2 / CATAPRES-TTS-3 | Closed |
Approval Letter ACTAVIS LABS UT INC (Jun 23, 2026) FDA posted an approval letter for FIORICET W/ CODEINE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FIORICET W/ CODEINE | Closed |
Approval Letter BRACCO (Jun 23, 2026) FDA posted an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ISOVUE-M 200 / ISOVUE-300 / ISOVUE-370 | Closed |
Approval Letter GENUS LIFESCIENCES (Jun 23, 2026) FDA posted an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200535 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OXYCODONE HYDROCHLORIDE | Closed |
Approval Letter PHOTOCURE ASA (Jun 23, 2026) FDA posted an approval letter for CYSVIEW KIT on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CYSVIEW KIT | Closed |
Approval Letter SUN PHARM INDUSTRIES (Jun 23, 2026) FDA posted an approval letter for SYNALGOS-DC on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SYNALGOS-DC | Closed |
Approval Letter HIKMA (Jun 23, 2026) FDA posted an approval letter for MORPHINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022207 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MORPHINE SULFATE | Closed |
Approval Letter ZYLA (Jun 23, 2026) FDA posted an approval letter for OXAYDO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202080 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OXAYDO | Closed |
Approval Letter CIPHER PHARMS INC (Jun 23, 2026) FDA posted an approval letter for CONZIP on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022370 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CONZIP | Closed |
Approval Letter ROSEMOUNT (Jun 23, 2026) FDA posted an approval letter for QDOLO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214044 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QDOLO | Closed |
Approval Letter AGIOS PHARMS INC (Jun 23, 2026) FDA posted an approval letter for PYRUKYND, AQVESME on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PYRUKYND / AQVESME | Closed |
Approval Letter GENUS LIFESCIENCES (Jun 23, 2026) FDA posted an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200534 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OXYCODONE HYDROCHLORIDE | Closed |
Approval Letter ENDO OPERATIONS (Jun 23, 2026) FDA posted an approval letter for PERCODAN-DEMI, PERCODAN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 007337 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PERCODAN-DEMI / PERCODAN | Closed |
Approval Letter HIKMA (Jun 23, 2026) FDA posted an approval letter for MORPHINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022195 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MORPHINE SULFATE | Closed |
Approval Letter BDSI (Jun 23, 2026) FDA posted an approval letter for BELBUCA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207932 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BELBUCA | Closed |
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026) FDA posted an approval letter for NUCYNTA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022304 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUCYNTA | Closed |
Approval Letter HIKMA (Jun 23, 2026) FDA posted an approval letter for CODEINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022402 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CODEINE SULFATE | Closed |
Approval Letter QUAGEN (Jun 23, 2026) FDA posted an approval letter for DEMEROL on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005010 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEMEROL | Closed |
Approval Letter SPECGX LLC (Jun 23, 2026) FDA posted an approval letter for ROXICODONE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021011 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROXICODONE | Closed |
Approval Letter VISTAPHARM LLC (Jun 23, 2026) FDA posted an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201194 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OXYCODONE HYDROCHLORIDE | Closed |
Approval Letter KNOA PHARMA (Jun 23, 2026) FDA posted an approval letter for BUTRANS on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021306 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BUTRANS | Closed |
Approval Letter PROTEGA PHARMS (Jun 23, 2026) FDA posted an approval letter for ROXYBOND on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROXYBOND | Closed |
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026) FDA posted an approval letter for NUCYNTA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUCYNTA ER | Closed |
Approval Letter KNOA PHARMA (Jun 23, 2026) FDA posted an approval letter for HYSINGLA ER on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206627 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HYSINGLA ER | Closed |
Approval Letter KNOA PHARMA (Jun 23, 2026) FDA posted an approval letter for OXYCONTIN on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022272 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OXYCONTIN | Closed |
Approval Letter GENENTECH INC (Jun 23, 2026) FDA posted an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LUNSUMIO / LUNSUMIO VELO | Closed |
Approval Letter HIKMA (Jun 23, 2026) FDA posted an approval letter for CODEINE SULFATE on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202245 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CODEINE SULFATE | Closed |
Approval Letter AGILE (Jun 23, 2026) FDA posted an approval letter for TWIRLA on 2026-06-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204017 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TWIRLA | Closed |
Approval Letter GLAXOSMITHKLINE (Jun 18, 2026) FDA posted an approval letter for UTEBZI on 2026-06-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215960 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA UTEBZI | Closed |
Approval Letter GENMAB US, INC. (Jun 18, 2026) FDA posted an approval letter for EPKINLY on 2026-06-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761324 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPKINLY | Closed |
Approval Letter HIKMA PHARMS (Jun 18, 2026) FDA posted an approval letter for PARICALCITOL on 2026-06-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205917 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PARICALCITOL | Closed |
Approval Letter NORWICH (Jun 18, 2026) FDA posted an approval letter for BALOXAVIR MARBOXIL on 2026-06-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217449 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BALOXAVIR MARBOXIL | Closed |
Approval Letter GENENTECH INC (Jun 18, 2026) FDA posted an approval letter for OCREVUS ZUNOVO on 2026-06-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761371 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OCREVUS ZUNOVO | Closed |
Approval Letter AZURITY (Jun 17, 2026) FDA posted an approval letter for APREPITANT on 2026-06-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218754 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA APREPITANT | Closed |
Approval Letter SANDOZ (Jun 17, 2026) FDA posted an approval letter for ARGATROBAN on 2026-06-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020883 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN | Closed |
Approval Letter KENVUE BRANDS (Jun 17, 2026) FDA posted an approval letter for IMODIUM MULTI-SYMPTOM RELIEF on 2026-06-17. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021140 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMODIUM MULTI-SYMPTOM RELIEF | Closed |
Approval Letter SUN PHARM (Jun 16, 2026) FDA posted an approval letter for ABSORICA LD, ABSORICA on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211913, NDA 021951 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABSORICA LD / ABSORICA | Closed |
Approval Letter MERCK SHARP DOHME (Jun 16, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Jun 16, 2026) FDA posted an approval letter for YERVOY on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125377 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YERVOY | Closed |
Approval Letter ASTRAZENECA (Jun 16, 2026) FDA posted an approval letter for TRUQAP on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRUQAP | Closed |
Approval Letter CARLSBAD (Jun 16, 2026) FDA posted an approval letter for CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, SKYRIZI on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 076126, BLA 761105 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE / SKYRIZI | Closed |
Approval Letter KENVUE BRANDS (Jun 16, 2026) FDA posted an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYRTEC ALLERGY / ZYRTEC HIVES | Closed |
Approval Letter AMPHASTAR PHARMS INC (Jun 16, 2026) FDA posted an approval letter for REXTOVY on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208969 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REXTOVY | Closed |
Approval Letter AZURITY (Jun 16, 2026) FDA posted an approval letter for WIDAPLIK on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219423 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WIDAPLIK | Closed |
Approval Letter MERCK SHARP DOHME (Jun 16, 2026) FDA posted an approval letter for WELIREG on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WELIREG | Closed |
Approval Letter HOFFMANN-LA ROCHE (Jun 15, 2026) FDA posted an approval letter for ALECENSA on 2026-06-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALECENSA | Closed |
Approval Letter BAXTER HLTHCARE (Jun 15, 2026) FDA posted an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 10% IN PLASTIC CONTAINER on 2026-06-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016673, NDA 016694 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEXTROSE 5% IN PLASTIC CONTAINER / DEXTROSE 10% IN PLASTIC CONTAINER | Closed |
Approval Letter ASTRAZENECA AB (Jun 15, 2026) FDA posted an approval letter for BAXFENDY on 2026-06-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219878 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BAXFENDY | Closed |
Approval Letter PROVENTION BIO INC (Jun 15, 2026) FDA posted an approval letter for TZIELD on 2026-06-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TZIELD | Closed |
Approval Letter HOSPIRA (Jun 11, 2026) FDA posted an approval letter for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206473 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Closed |
Approval Letter GLAXOSMITHKLINE LLC (Jun 11, 2026) FDA posted an approval letter for EXDENSUR on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761458 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EXDENSUR | Closed |
Approval Letter CIPLA (Jun 11, 2026) FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022434 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN SODIUM CHLORIDE | Closed |
Approval Letter BAXTER HLTHCARE (Jun 11, 2026) FDA posted an approval letter for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050671 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER | Closed |
Approval Letter SERVIER (Jun 11, 2026) FDA posted an approval letter for VORANIGO on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218784 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VORANIGO | Closed |
Approval Letter ALCON LABS INC (Jun 11, 2026) FDA posted an approval letter for FLUORESCITE on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021980 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUORESCITE | Closed |
Approval Letter JANSSEN BIOTECH (Jun 11, 2026) FDA posted an approval letter for DARZALEX on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761036 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DARZALEX | Closed |
Approval Letter MALLINCKRODT IRELAND (Jun 11, 2026) FDA posted an approval letter for TERLIVAZ on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022231 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TERLIVAZ | Closed |
Approval Letter BRISTOL (Jun 11, 2026) FDA posted an approval letter for SOTYKTU on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOTYKTU | Closed |
Approval Letter PFIZER (Jun 11, 2026) FDA posted an approval letter for ZYVOX on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021130, NDA 021131, NDA 021132 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYVOX | Closed |
Approval Letter ELI LILLY AND CO (Jun 11, 2026) FDA posted an approval letter for EBGLYSS on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761306 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EBGLYSS | Closed |
Approval Letter EUGIA PHARMA SPECLTS (Jun 11, 2026) FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209552 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN SODIUM CHLORIDE | Closed |
Approval Letter GLAXOSMITHKLINE (Jun 11, 2026) FDA posted an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MALARONE / MALARONE PEDIATRIC | Closed |
Approval Letter AUROBINDO PHARMA (Jun 11, 2026) FDA posted an approval letter for CEPHALEXIN on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213568 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEPHALEXIN | Closed |
Approval Letter ACTAVIS LABS FL INC (Jun 9, 2026) FDA posted an approval letter for RIFAXIMIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208959 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIFAXIMIN | Closed |
Approval Letter TEVA PHARMS USA INC (Jun 9, 2026) FDA posted an approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211583 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Closed |
Approval Letter SANDOZ (Jun 9, 2026) FDA posted an approval letter for MESALAMINE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219997 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MESALAMINE | Closed |
Approval Letter METHAPHARM (Jun 9, 2026) FDA posted an approval letter for PROVOCHOLINE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019193 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROVOCHOLINE | Closed |
Approval Letter APOTEX (Jun 9, 2026) FDA posted an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210456 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) | Closed |
Approval Letter APOTEX (Jun 9, 2026) FDA posted an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210671 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MULTIPLE VITAMINS INJECTION PEDIATRIC | Closed |
Approval Letter APOTEX (Jun 9, 2026) FDA posted an approval letter for CANAGLIFLOZIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CANAGLIFLOZIN | Closed |
Approval Letter APOTEX (Jun 9, 2026) FDA posted an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210273 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MULTIPLE VITAMINS INJECTION ADULT | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Jun 9, 2026) FDA posted an approval letter for OPDUALAG on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761234 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPDUALAG | Closed |
Approval Letter PFIZER INC (Jun 9, 2026) FDA posted an approval letter for HYMPAVZI on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761369 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HYMPAVZI | Closed |
Approval Letter JAZZ PHARMS RES (Jun 9, 2026) FDA posted an approval letter for EPIDIOLEX on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210365 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPIDIOLEX | Closed |
Approval Letter ELI LILLY AND CO (Jun 9, 2026) FDA posted an approval letter for EMGALITY on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761063 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EMGALITY | Closed |
Approval Letter CIPLA (Jun 9, 2026) FDA posted an approval letter for NINTEDANIB ESYLATE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212609 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NINTEDANIB ESYLATE | Closed |
Approval Letter MYLAN (Jun 9, 2026) FDA posted an approval letter for APREPITANT on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA APREPITANT | Closed |
Approval Letter CIPLA (Jun 9, 2026) FDA posted an approval letter for ALBUTEROL SULFATE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219409 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALBUTEROL SULFATE | Closed |
Approval Letter MSN (Jun 9, 2026) FDA posted an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE | Closed |
Approval Letter SANDOZ (Jun 9, 2026) FDA posted an approval letter for ENZALUTAMIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216068 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENZALUTAMIDE | Closed |
Approval Letter AUROBINDO PHARMA LTD (Jun 9, 2026) FDA posted an approval letter for CITALOPRAM HYDROBROMIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219985 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CITALOPRAM HYDROBROMIDE | Closed |
Approval Letter ACCORD BIOPHARMA INC. (Jun 9, 2026) FDA posted an approval letter for IMULDOSA on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761364 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMULDOSA | Closed |
Approval Letter Lundbeck Seattle BioPharmaceuticals, Inc. (Jun 9, 2026) FDA posted an approval letter for VYEPTI on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761119 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYEPTI | Closed |
Approval Letter TEVA PHARMS USA (Jun 9, 2026) FDA posted an approval letter for FERRIC CITRATE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212563 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FERRIC CITRATE | Closed |
Approval Letter INVENTIA (Jun 9, 2026) FDA posted an approval letter for DAPAGLIFLOZIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DAPAGLIFLOZIN | Closed |
Approval Letter AUROBINDO PHARMA LTD (Jun 8, 2026) FDA posted an approval letter for TOFACITINIB CITRATE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215356 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TOFACITINIB CITRATE | Closed |
Approval Letter SAGENT (Jun 8, 2026) FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220483 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | Closed |
Approval Letter CHATTEM SANOFI (Jun 8, 2026) FDA posted an approval letter for CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021909 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ALLEGRA ALLERGY / CHILDREN'S ALLEGRA HIVES | Closed |
Approval Letter MSD SUB MERCK (Jun 5, 2026) FDA posted an approval letter for STEGLUJAN on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209805 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STEGLUJAN | Closed |
Approval Letter ASTRAZENECA AB (Jun 5, 2026) FDA posted an approval letter for FASENRA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761070 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FASENRA | Closed |
Approval Letter MSD SUB MERCK (Jun 5, 2026) FDA posted an approval letter for STEGLATRO on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209803 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STEGLATRO | Closed |
Approval Letter ASTRAZENECA AB (Jun 5, 2026) FDA posted an approval letter for FARXIGA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202293 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FARXIGA | Closed |
Approval Letter ASTRAZENECA AB (Jun 5, 2026) FDA posted an approval letter for QTERN on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209091 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QTERN | Closed |
Approval Letter SANDOZ (Jun 5, 2026) FDA posted an approval letter for ARGATROBAN IN DEXTROSE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201743 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN DEXTROSE | Closed |
Approval Letter JANSSEN PHARMS (Jun 5, 2026) FDA posted an approval letter for INVOKANA on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INVOKANA | Closed |
Approval Letter THERACOSBIO (Jun 5, 2026) FDA posted an approval letter for BRENZAVVY on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214373 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRENZAVVY | Closed |
Approval Letter EPIC PHARMA LLC (Jun 3, 2026) FDA posted an approval letter for FUROSEMIDE on 2026-06-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018569 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FUROSEMIDE | Closed |
Approval Letter NOVO (Jun 3, 2026) FDA posted an approval letter for SAXENDA on 2026-06-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SAXENDA | Closed |
Approval Letter LUPIN LIMITED (Jun 3, 2026) FDA posted an approval letter for RANLUSPEC on 2026-06-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761480 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RANLUSPEC | Closed |
Approval Letter SABA ILAC SANAYI (Jun 2, 2026) FDA posted an approval letter for ARFORMOTEROL TARTRATE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218429 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARFORMOTEROL TARTRATE | Closed |
Approval Letter WOCKHARDT BIO AG (Jun 2, 2026) FDA posted an approval letter for ZAYNICH on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220787 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZAYNICH | Closed |
Approval Letter MSN (Jun 2, 2026) FDA posted an approval letter for BRIVARACETAM on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214924 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRIVARACETAM | Closed |
Approval Letter CYCLE (Jun 2, 2026) FDA posted an approval letter for CAVHANZA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217379 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAVHANZA | Closed |
Approval Letter SHIONOGI (Jun 2, 2026) FDA posted an approval letter for XOCOVA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220442 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XOCOVA | Closed |
Approval Letter NOVO (Jun 2, 2026) FDA posted an approval letter for OZEMPIC on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OZEMPIC | Closed |
Approval Letter GLAXOSMITHKLINE (Jun 2, 2026) FDA posted an approval letter for WELLCOVORIN on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018342 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WELLCOVORIN | Closed |
Approval Letter NATCO (Jun 2, 2026) FDA posted an approval letter for IDELALISIB on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216921 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDELALISIB | Closed |
Approval Letter TEVA PHARMS USA (Jun 2, 2026) FDA posted an approval letter for AJOVY on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761089 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AJOVY | Closed |
Approval Letter MERCK SHARP DOHME (Jun 2, 2026) FDA posted an approval letter for KEYTRUDA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter ALEXION PHARM (Jun 2, 2026) FDA posted an approval letter for SOLIRIS, ULTOMIRIS on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125166, BLA 761108 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOLIRIS / ULTOMIRIS | Closed |
Approval Letter ARMSTRONG PHARMS (Jun 2, 2026) FDA posted an approval letter for IPRATROPIUM BROMIDE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217953 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IPRATROPIUM BROMIDE | Closed |
Approval Letter NOVARTIS (Jun 2, 2026) FDA posted an approval letter for AFINITOR, AFINITOR DISPERZ on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022334, NDA 203985 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AFINITOR / AFINITOR DISPERZ | Closed |
Approval Letter HAISCO (Jun 2, 2026) FDA posted an approval letter for CYPSEDO on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220482 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CYPSEDO | Closed |
Approval Letter MANNKIND (Jun 2, 2026) FDA posted an approval letter for AFREZZA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AFREZZA | Closed |
Approval Letter SHORLA (May 29, 2026) FDA posted an approval letter for JYLAMVO on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212479 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JYLAMVO | Closed |
Approval Letter ASTRAZENECA UK LTD (May 29, 2026) FDA posted an approval letter for IMFINZI on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761069 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMFINZI | Closed |
Approval Letter DELCATH SYSTEMS INC (May 29, 2026) FDA posted an approval letter for HEPZATO on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HEPZATO | Closed |
Approval Letter JANSSEN BIOTECH (May 29, 2026) FDA posted an approval letter for TREMFYA on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761061 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TREMFYA | Closed |
Approval Letter AZURITY (May 29, 2026) FDA posted an approval letter for FERAHEME on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022180 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FERAHEME | Closed |
Approval Letter GENENTECH INC (May 29, 2026) FDA posted an approval letter for COLUMVI on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COLUMVI | Closed |
Approval Letter ABBVIE INC (May 29, 2026) FDA posted an approval letter for DECNUPAZ on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761460 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DECNUPAZ | Closed |
Approval Letter ASTRAZENECA (May 29, 2026) FDA posted an approval letter for TRUQAP on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRUQAP | Closed |
Approval Letter ORGANON (May 29, 2026) FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMPLANON / NEXPLANON | Closed |
Approval Letter AZURITY (May 29, 2026) FDA posted an approval letter for XATMEP on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208400 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XATMEP | Closed |
Approval Letter UCB INC (May 27, 2026) FDA posted an approval letter for FINTEPLA on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212102 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FINTEPLA | Closed |
Approval Letter SENTYNL THERAPS INC (May 27, 2026) FDA posted an approval letter for NULIBRY on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214018 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NULIBRY | Closed |
Approval Letter ASTRAZENECA (May 27, 2026) FDA posted an approval letter for KOSELUGO on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213756, NDA 219943 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KOSELUGO | Closed |
Approval Letter ASTRAZENECA (May 27, 2026) FDA posted an approval letter for CRESTOR on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CRESTOR | Closed |
Approval Letter DAIICHI SANKYO INC (May 27, 2026) FDA posted an approval letter for DATROWAY on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761394 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DATROWAY | Closed |
Approval Letter BIOGEN MA (May 27, 2026) FDA posted an approval letter for TOFIDENCE on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761354 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TOFIDENCE | Closed |
Approval Letter ACTELION (May 27, 2026) FDA posted an approval letter for UPTRAVI on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207947, NDA 214275 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA UPTRAVI | Closed |
Approval Letter ABBVIE (May 26, 2026) FDA posted an approval letter for VENCLEXTA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VENCLEXTA | Closed |
Approval Letter ABBVIE (May 26, 2026) FDA posted an approval letter for LINZESS on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202811 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LINZESS | Closed |
Approval Letter HOSPIRA INC (May 26, 2026) FDA posted an approval letter for NYVEPRIA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761111 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NYVEPRIA | Closed |
Approval Letter APOTEX (May 26, 2026) FDA posted an approval letter for CANAGLIFLOZIN on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CANAGLIFLOZIN | Closed |
Approval Letter RUBICON RESEARCH (May 26, 2026) FDA posted an approval letter for CLONAZEPAM on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216988 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLONAZEPAM | Closed |
Approval Letter BOSTON SCITFC (May 26, 2026) FDA posted an approval letter for VARITHENA on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205098 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VARITHENA | Closed |
Approval Letter NATCO (May 26, 2026) FDA posted an approval letter for THALIDOMIDE on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213267 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA THALIDOMIDE | Closed |
Approval Letter ACCORD HLTHCARE (May 26, 2026) FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN IN SODIUM CHLORIDE | Closed |
Approval Letter GILEAD SCIENCES INC (May 26, 2026) FDA posted an approval letter for HEPCLUDEX on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761468 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HEPCLUDEX | Closed |
Approval Letter APOTEX (May 26, 2026) FDA posted an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210672 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MULTIPLE VITAMINS INJECTION ADULT | Closed |
Approval Letter GALDERMA LABS LP (May 22, 2026) FDA posted an approval letter for DIFFERIN EPIDUO, DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) on 2026-05-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220736 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIFFERIN EPIDUO / DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) | Closed |
Approval Letter ABBVIE (May 21, 2026) FDA posted an approval letter for RINVOQ LQ on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RINVOQ LQ | Closed |
Approval Letter BAYER HEALTHCARE LLC (May 21, 2026) FDA posted an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S CLARITIN / CLARITIN | Closed |
Approval Letter FRESENIUS KABI USA (May 21, 2026) FDA posted an approval letter for TYENNE on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761449 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYENNE | Closed |
Approval Letter CHATTEM SANOFI (May 21, 2026) FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209089 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XYZAL ALLERGY 24HR | Closed |
Approval Letter FRESENIUS KABI USA (May 21, 2026) FDA posted an approval letter for TYENNE on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYENNE | Closed |
Approval Letter MIRUM (May 21, 2026) FDA posted an approval letter for CHOLBAM on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205750 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHOLBAM | Closed |
Approval Letter ORGANON (May 21, 2026) FDA posted an approval letter for REMERON on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020415 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REMERON | Closed |
Approval Letter INCYTE CORP (May 19, 2026) FDA posted an approval letter for ZYNYZ on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761334 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYNYZ | Closed |
Approval Letter GENENTECH INC (May 19, 2026) FDA posted an approval letter for PHESGO on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761170 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PHESGO | Closed |
Approval Letter GENENTECH (May 19, 2026) FDA posted an approval letter for HERCEPTIN, HERCEPTIN HYLECTA on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103792, BLA 761106 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HERCEPTIN / HERCEPTIN HYLECTA | Closed |
Approval Letter HIKMA PHARM CO LTD (May 19, 2026) FDA posted an approval letter for ARGATROBAN on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203049 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARGATROBAN | Closed |
Approval Letter DAIICHI SANKYO (May 19, 2026) FDA posted an approval letter for ENHERTU on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENHERTU | Closed |
Approval Letter IMPAX (May 19, 2026) FDA posted an approval letter for CREXONT on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217186 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CREXONT | Closed |
Approval Letter GENENTECH INC (May 19, 2026) FDA posted an approval letter for TECENTRIQ on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TECENTRIQ | Closed |
Approval Letter MDD US (May 19, 2026) FDA posted an approval letter for ONAPGO on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ONAPGO | Closed |
Approval Letter EMD SERONO INC (May 18, 2026) FDA posted an approval letter for MAVENCLAD on 2026-05-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022561 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MAVENCLAD | Closed |
Approval Letter CHIESI (May 18, 2026) FDA posted an approval letter for TRIMBOW on 2026-05-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219622 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRIMBOW | Closed |
Approval Letter ACCORD BIOPHARMA INC. (May 18, 2026) FDA posted an approval letter for IMMGOLIS, IMMGOLIS INTRI on 2026-05-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761452 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMMGOLIS / IMMGOLIS INTRI | Closed |
Approval Letter TAIHO ONCOLOGY (May 15, 2026) FDA posted an approval letter for INQOVI on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212576 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INQOVI | Closed |
Approval Letter SUN PHARM (May 15, 2026) FDA posted an approval letter for YONSA on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210308 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YONSA | Closed |
Approval Letter PARATEK PHARMS (May 15, 2026) FDA posted an approval letter for NUZYRA on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209816, NDA 209817 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUZYRA | Closed |
Approval Letter BEONE MEDICINES USA (May 15, 2026) FDA posted an approval letter for BEQALZI on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220711 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BEQALZI | Closed |
Approval Letter MERCK SHARP DOHME (May 13, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter MERCK SHARP DOHME (May 13, 2026) FDA posted an approval letter for KEYTRUDA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter GENENTECH INC (May 13, 2026) FDA posted an approval letter for TECENTRIQ HYBREZA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761347 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TECENTRIQ HYBREZA | Closed |
Approval Letter BRACCO (May 13, 2026) FDA posted an approval letter for CARDIOGEN-82 on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019414 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CARDIOGEN-82 | Closed |
Approval Letter CUBIST PHARMS LLC (May 13, 2026) FDA posted an approval letter for ZERBAXA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206829 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZERBAXA | Closed |
Approval Letter BRISTOL MYERS SQUIBB (May 13, 2026) FDA posted an approval letter for OPDIVO on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPDIVO | Closed |
Approval Letter SANDOZ INC (May 13, 2026) FDA posted an approval letter for ZIEXTENZO on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761045 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIEXTENZO | Closed |
Approval Letter AMGEN INC (May 13, 2026) FDA posted an approval letter for WEZLANA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761285, BLA 761331 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WEZLANA | Closed |
Approval Letter AMNEAL (May 13, 2026) FDA posted an approval letter for PYRIDOSTIGMINE BROMIDE on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217604 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PYRIDOSTIGMINE BROMIDE | Closed |
Approval Letter GENENTECH INC (May 13, 2026) FDA posted an approval letter for TECENTRIQ on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TECENTRIQ | Closed |
Approval Letter B BRAUN (May 13, 2026) FDA posted an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016730 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEXTROSE 5% IN PLASTIC CONTAINER | Closed |
Approval Letter BRISTOL-MYERS SQUIBB (May 13, 2026) FDA posted an approval letter for OPDIVO QVANTIG on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761381 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPDIVO QVANTIG | Closed |
Approval Letter NOVARTIS (May 12, 2026) FDA posted an approval letter for DIOVAN on 2026-05-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021283 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIOVAN | Closed |
Approval Letter ACCORD BIOPHARMA INC. (May 12, 2026) FDA posted an approval letter for ENNUMO on 2026-05-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761147 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENNUMO | Closed |
Approval Letter ARGENX BV (May 11, 2026) FDA posted an approval letter for VYVGART, VYVGART HYTRULO on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761195, BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYVGART / VYVGART HYTRULO | Closed |
Approval Letter BRILLIAN PHARMA (May 11, 2026) FDA posted an approval letter for SDAMLO on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219531 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SDAMLO | Closed |
Approval Letter BAYER HLTHCARE (May 11, 2026) FDA posted an approval letter for ADEMPAS on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204819 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADEMPAS | Closed |
Approval Letter CEDIPROF INC (May 11, 2026) FDA posted an approval letter for LEVO-T on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021342 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEVO-T | Closed |
Approval Letter PFIZER (May 11, 2026) FDA posted an approval letter for NURTEC ODT on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212728 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NURTEC ODT | Closed |
Approval Letter ASTRAZENECA (May 11, 2026) FDA posted an approval letter for BRILINTA on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022433 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRILINTA | Closed |
Approval Letter GENENTECH INC (May 11, 2026) FDA posted an approval letter for OCREVUS on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761053 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OCREVUS | Closed |
Approval Letter CHEPLAPHARM (May 11, 2026) FDA posted an approval letter for ZYPREXA RELPREVV on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYPREXA RELPREVV | Closed |
Approval Letter NOVARTIS (May 11, 2026) FDA posted an approval letter for MEKINIST on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204114 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MEKINIST | Closed |
Approval Letter MERUS N.V. (May 11, 2026) FDA posted an approval letter for BIZENGRI on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761352 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIZENGRI | Closed |
Approval Letter KING PHARMS LLC (May 11, 2026) FDA posted an approval letter for ALTACE on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019901 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALTACE | Closed |
Approval Letter VALEANT LUXEMBOURG (May 11, 2026) FDA posted an approval letter for SILIQ on 2026-05-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SILIQ | Closed |
Approval Letter ABBVIE ENDOCRINE INC (May 8, 2026) FDA posted an approval letter for LUPRON on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019010 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LUPRON | Closed |
Approval Letter TERSERA (May 8, 2026) FDA posted an approval letter for ZOLADEX on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020578 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZOLADEX | Closed |
Approval Letter TOLMAR (May 8, 2026) FDA posted an approval letter for ELIGARD KIT on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021343, NDA 021379, NDA 021488, NDA 021731 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELIGARD KIT | Closed |
Approval Letter ENDO OPERATIONS (May 8, 2026) FDA posted an approval letter for VANTAS on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021732 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VANTAS | Closed |
Approval Letter TERSERA (May 8, 2026) FDA posted an approval letter for ZOLADEX on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019726, NDA 020515 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZOLADEX | Closed |
Approval Letter JANSSEN BIOTECH (May 8, 2026) FDA posted an approval letter for TECVAYLI, TALVEY on 2026-05-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761291, BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TECVAYLI / TALVEY | Closed |
Approval Letter AXSOME (May 6, 2026) FDA posted an approval letter for AUVELITY on 2026-05-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215430 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AUVELITY | Closed |
Approval Letter OTSUKA (May 4, 2026) FDA posted an approval letter for REXULTI on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205422 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REXULTI | Closed |
Approval Letter JANSSEN BIOTECH (May 4, 2026) FDA posted an approval letter for LAZCLUZE on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219008 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LAZCLUZE | Closed |
Approval Letter KRAMER (May 4, 2026) FDA posted an approval letter for NIZORAL ANTI-DANDRUFF on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020310 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NIZORAL ANTI-DANDRUFF | Closed |
Approval Letter EXTROVIS (May 4, 2026) FDA posted an approval letter for CARAC on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020985 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CARAC | Closed |
Approval Letter HOSPIRA (May 4, 2026) FDA posted an approval letter for PRECEDEX on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021038 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PRECEDEX | Closed |
Approval Letter RIGEL PHARMS (May 4, 2026) FDA posted an approval letter for VEPPANU on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219835 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VEPPANU | Closed |
Approval Letter MAP77 (May 4, 2026) FDA posted an approval letter for ATONCY on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220320 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ATONCY | Closed |
Approval Letter HOSPIRA (May 4, 2026) FDA posted an approval letter for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020201 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | Closed |
Approval Letter INCYTE CORP (May 4, 2026) FDA posted an approval letter for JAKAFI XR on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217180 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JAKAFI XR | Closed |
Approval Letter KARYOPHARM THERAPS (May 4, 2026) FDA posted an approval letter for XPOVIO on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212306 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XPOVIO | Closed |
Approval Letter HALEON US HOLDINGS (May 4, 2026) FDA posted an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED | Closed |
Approval Letter HALEON US HOLDINGS (May 4, 2026) FDA posted an approval letter for CHILDREN'S ADVIL, JUNIOR STRENGTH ADVIL on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020944 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ADVIL / JUNIOR STRENGTH ADVIL | Closed |
Approval Letter HQ SPCLT PHARMA (May 4, 2026) FDA posted an approval letter for DEXMEDETOMIDINE HYDROCHLORIDE on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206628 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEXMEDETOMIDINE HYDROCHLORIDE | Closed |
Approval Letter APOTEX (May 4, 2026) FDA posted an approval letter for EVDI on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220837 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EVDI | Closed |
Approval Letter DAIICHI SANKYO INC (May 1, 2026) FDA posted an approval letter for VANFLYTA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VANFLYTA | Closed |
Approval Letter ASTRAZENECA AB (May 1, 2026) FDA posted an approval letter for BREZTRI AEROSPHERE on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212122 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BREZTRI AEROSPHERE | Closed |
Approval Letter ACADIA PHARMS INC (May 1, 2026) FDA posted an approval letter for NUPLAZID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207318, NDA 210793 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NUPLAZID | Closed |
Approval Letter SUNSHINE LAKE PHARMA CO LTD (May 1, 2026) FDA posted an approval letter for LANGLARA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761412 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LANGLARA | Closed |
Approval Letter ASTRAZENECA (May 1, 2026) FDA posted an approval letter for SYMBICORT AEROSPHERE on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216579 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SYMBICORT AEROSPHERE | Closed |
Approval Letter DAIICHI SANKYO (May 1, 2026) FDA posted an approval letter for ENHERTU on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761139 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENHERTU | Closed |
Approval Letter BRISTOL-MYERS (May 1, 2026) FDA posted an approval letter for THALOMID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020785 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA THALOMID | Closed |
Approval Letter BRISTOL MYERS SQUIBB (May 1, 2026) FDA posted an approval letter for REVLIMID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REVLIMID | Closed |
Approval Letter PFIZER IRELAND PHARMACEUTICALS (May 1, 2026) FDA posted an approval letter for NGENLA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761184 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NGENLA | Closed |
Approval Letter BRISTOL (May 1, 2026) FDA posted an approval letter for POMALYST on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204026 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POMALYST | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Apr 30, 2026) FDA posted an approval letter for EPYSQLI on 2026-04-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPYSQLI | Closed |
Approval Letter AMGEN INC (Apr 30, 2026) FDA posted an approval letter for PAVBLU on 2026-04-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761298 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PAVBLU | Closed |
Approval Letter ZYDUS LIFESCIENCES (Apr 28, 2026) FDA posted an approval letter for ZITUVIMET on 2026-04-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216743 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZITUVIMET | Closed |
Approval Letter KYOWA KIRIN (Apr 27, 2026) FDA posted an approval letter for CRYSVITA on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761068 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CRYSVITA | Closed |
Approval Letter GENENTECH (Apr 27, 2026) FDA posted an approval letter for PERJETA on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125409 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PERJETA | Closed |
Approval Letter PHATHOM (Apr 27, 2026) FDA posted an approval letter for VOQUEZNA TRIPLE PAK on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215152 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VOQUEZNA TRIPLE PAK | Closed |
Approval Letter MERCK SHARP DOHME (Apr 27, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter BAYER HEALTHCARE LLC (Apr 27, 2026) FDA posted an approval letter for CLARITIN on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021952 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLARITIN | Closed |
Approval Letter TAKEDA PHARMS USA (Apr 27, 2026) FDA posted an approval letter for ADDERALL XR 10, ADDERALL XR 20, ADDERALL XR 30 on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021303, NDA 021977, NDA 022063, NDA 208510 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADDERALL XR 10 / ADDERALL XR 20 / ADDERALL XR 30 | Closed |
Approval Letter B BRAUN (Apr 27, 2026) FDA posted an approval letter for METRO I.V. IN PLASTIC CONTAINER on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018900 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA METRO I.V. IN PLASTIC CONTAINER | Closed |
Approval Letter ASTRAZENECA AB (Apr 27, 2026) FDA posted an approval letter for SAPHNELO on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761451 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SAPHNELO | Closed |
Approval Letter INTRA-CELLULAR (Apr 27, 2026) FDA posted an approval letter for CAPLYTA on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209500 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAPLYTA | Closed |
Approval Letter BAYER HEALTHCARE LLC (Apr 27, 2026) FDA posted an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-04-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S CLARITIN / CLARITIN | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Apr 24, 2026) FDA posted an approval letter for DUPIXENT on 2026-04-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUPIXENT | Closed |
Approval Letter RENEW PHARMS (Apr 24, 2026) FDA posted an approval letter for IC-GREEN on 2026-04-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IC-GREEN | Closed |
Approval Letter JANSSEN PHARMS (Apr 21, 2026) FDA posted an approval letter for SPRAVATO on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPRAVATO | Closed |
Approval Letter MSD (Apr 21, 2026) FDA posted an approval letter for IDVYNSO on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216964 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDVYNSO | Closed |
Approval Letter BIOGEN (Apr 21, 2026) FDA posted an approval letter for ZURZUVAE on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217369 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZURZUVAE | Closed |
Approval Letter PROVENTION BIO INC (Apr 21, 2026) FDA posted an approval letter for TZIELD on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TZIELD | Closed |
Approval Letter AZURITY (Apr 20, 2026) FDA posted an approval letter for DANZITEN on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219293 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DANZITEN | Closed |
Approval Letter HALEON US HOLDINGS (Apr 20, 2026) FDA posted an approval letter for ABREVA on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020941 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABREVA | Closed |
Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026) FDA posted an approval letter for COSENTYX on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COSENTYX | Closed |
Approval Letter NOVARTIS PHARMS CORP (Apr 20, 2026) FDA posted an approval letter for COSENTYX on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761349, BLA 125504 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COSENTYX | Closed |
Approval Letter SANDOZ INC (Apr 20, 2026) FDA posted an approval letter for ZARXIO on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125553 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZARXIO | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Apr 20, 2026) FDA posted an approval letter for DUPIXENT on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUPIXENT | Closed |
Approval Letter BIOCODEX SA (Apr 16, 2026) FDA posted an approval letter for DIACOMIT on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206709, NDA 207223 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIACOMIT | Closed |
Approval Letter GE HLTHCARE INC (Apr 16, 2026) FDA posted an approval letter for DATSCAN on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022454 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DATSCAN | Closed |
Approval Letter ASTRAZENECA AB (Apr 16, 2026) FDA posted an approval letter for WAINUA (AUTOINJECTOR), WAINUA on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217388 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WAINUA (AUTOINJECTOR) / WAINUA | Closed |
Approval Letter JANSSEN BIOTECH (Apr 16, 2026) FDA posted an approval letter for STELARA on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STELARA | Closed |
Approval Letter GENENTECH INC (Apr 16, 2026) FDA posted an approval letter for ITOVEBI on 2026-04-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219249 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ITOVEBI | Closed |
Approval Letter AMIVAS (Apr 15, 2026) FDA posted an approval letter for ARTESUNATE on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213036 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARTESUNATE | Closed |
Approval Letter DAIICHI SANKYO INC (Apr 15, 2026) FDA posted an approval letter for VANFLYTA on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VANFLYTA | Closed |
Approval Letter DENALI THERAPEUTICS INC. (Apr 15, 2026) FDA posted an approval letter for AVLAYAH on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761485 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVLAYAH | Closed |
Approval Letter GERON (Apr 15, 2026) FDA posted an approval letter for RYTELO on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217779 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYTELO | Closed |
Approval Letter TRAVERE (Apr 15, 2026) FDA posted an approval letter for FILSPARI on 2026-04-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216403 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FILSPARI | Closed |
Approval Letter SANDOZ (Apr 14, 2026) FDA posted an approval letter for TOBRADEX on 2026-04-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050592 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TOBRADEX | Closed |
Approval Letter JANSSEN PHARMS (Apr 13, 2026) FDA posted an approval letter for CONCERTA on 2026-04-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021121 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CONCERTA | Closed |
Approval Letter THEA PHARMA (Apr 10, 2026) FDA posted an approval letter for COSOPT PF on 2026-04-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202667 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COSOPT PF | Closed |
Approval Letter GENENTECH INC (Apr 10, 2026) FDA posted an approval letter for VABYSMO on 2026-04-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761235 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VABYSMO | Closed |
Approval Letter BRISTOL (Apr 10, 2026) FDA posted an approval letter for ONUREG on 2026-04-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214120 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ONUREG | Closed |
Approval Letter SCIENTURE (Apr 10, 2026) FDA posted an approval letter for REZENOPY on 2026-04-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215487 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REZENOPY | Closed |
Approval Letter B BRAUN (Apr 9, 2026) FDA posted an approval letter for CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050821 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | Closed |
Approval Letter VERTEX PHARMS INC (Apr 9, 2026) FDA posted an approval letter for TRIKAFTA (COPACKAGED) on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRIKAFTA (COPACKAGED) | Closed |
Approval Letter NOVARTIS (Apr 9, 2026) FDA posted an approval letter for PLUVICTO on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215833 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PLUVICTO | Closed |
Approval Letter BIOGEN US (Apr 9, 2026) FDA posted an approval letter for SKYCLARYS on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216718 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SKYCLARYS | Closed |
Approval Letter ASTRAZENECA AB (Apr 9, 2026) FDA posted an approval letter for BEYFORTUS on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761328 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BEYFORTUS | Closed |
Approval Letter NEUROCRINE (Apr 9, 2026) FDA posted an approval letter for INGREZZA SPRINKLE on 2026-04-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218390 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INGREZZA SPRINKLE | Closed |
Approval Letter ABBVIE (Apr 7, 2026) FDA posted an approval letter for MAVYRET on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209394 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MAVYRET | Closed |
Approval Letter BPI LABS (Apr 7, 2026) FDA posted an approval letter for ABLYSINOL on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207987 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABLYSINOL | Closed |
Approval Letter BAUSCH (Apr 7, 2026) FDA posted an approval letter for RETIN-A MICRO, RETIN-A-MICRO on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020475 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RETIN-A MICRO / RETIN-A-MICRO | Closed |
Approval Letter UNITED THERAP (Apr 7, 2026) FDA posted an approval letter for TYVASO on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022387 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYVASO | Closed |
Approval Letter HERON THERAPS INC (Apr 7, 2026) FDA posted an approval letter for ZYNRELEF KIT on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211988 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYNRELEF KIT | Closed |
Approval Letter MERCK SHARP DOHME (Apr 7, 2026) FDA posted an approval letter for KEYTRUDA on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter MERCK SHARP DOHME (Apr 7, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-04-07. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Apr 6, 2026) FDA posted an approval letter for EYLEA HD on 2026-04-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761355 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EYLEA HD | Closed |
Approval Letter APOTEX (Apr 6, 2026) FDA posted an approval letter for NINTEDANIB ESYLATE on 2026-04-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219227 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NINTEDANIB ESYLATE | Closed |
Approval Letter BIONPHARMA (Apr 2, 2026) FDA posted an approval letter for STAVZOR on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022152 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STAVZOR | Closed |
Approval Letter MERZ (Apr 2, 2026) FDA posted an approval letter for INBRIJA on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INBRIJA | Closed |
Approval Letter ELI LILLY AND CO (Apr 2, 2026) FDA posted an approval letter for FOUNDAYO on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220934 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOUNDAYO | Closed |
Approval Letter NOVARTIS (Apr 2, 2026) FDA posted an approval letter for ARZERRA, KESIMPTA on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125326 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARZERRA / KESIMPTA | Closed |
Approval Letter AKEBIA (Apr 2, 2026) FDA posted an approval letter for VAFSEO on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215192 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VAFSEO | Closed |
Approval Letter ABBVIE (Apr 2, 2026) FDA posted an approval letter for DEPAKOTE, DEPAKOTE ER on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018723, NDA 019680, NDA 021168 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DEPAKOTE / DEPAKOTE ER | Closed |
Approval Letter PYROS PHARMS (Apr 1, 2026) FDA posted an approval letter for VIGAFYDE on 2026-04-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217684 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VIGAFYDE | Closed |
Approval Letter IBSA INST BIO (Mar 31, 2026) FDA posted an approval letter for LICART on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206976 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LICART | Closed |
Approval Letter GENMAB US, INC. (Mar 31, 2026) FDA posted an approval letter for EPKINLY on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761324 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPKINLY | Closed |
Approval Letter CHIESI (Mar 31, 2026) FDA posted an approval letter for CARDENE, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019734 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CARDENE / CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER / CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | Closed |
Approval Letter INCYTE CORP (Mar 31, 2026) FDA posted an approval letter for ZYNYZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761334 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYNYZ | Closed |
Approval Letter TEVA PHARMACEUTICALS, INC. (Mar 31, 2026) FDA posted an approval letter for PONLIMSI on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761385 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PONLIMSI | Closed |
Approval Letter HALEON US HOLDINGS (Mar 31, 2026) FDA posted an approval letter for ALLI on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021887 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALLI | Closed |
Approval Letter STERISCIENCE (Mar 31, 2026) FDA posted an approval letter for FOCINVEZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216686 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOCINVEZ | Closed |
Approval Letter BAXTER HLTHCARE CORP (Mar 31, 2026) FDA posted an approval letter for EPINEPHRINE on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220626 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPINEPHRINE | Closed |
Approval Letter GLAXOSMITHKLINE (Mar 31, 2026) FDA posted an approval letter for ZEJULA on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214876 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEJULA | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 31, 2026) FDA posted an approval letter for BYOOVIZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BYOOVIZ | Closed |
Approval Letter BIOGEN (Mar 31, 2026) FDA posted an approval letter for SPINRAZA on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209531 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPINRAZA | Closed |
Approval Letter ACADIA PHARMS INC (Mar 31, 2026) FDA posted an approval letter for DAYBUE on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217026 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DAYBUE | Closed |
Approval Letter NOVO NORDISK INC (Mar 31, 2026) FDA posted an approval letter for AWIQLI FLEXTOUCH on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761326 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AWIQLI FLEXTOUCH | Closed |
Approval Letter VERTEX PHARMS INC (Mar 31, 2026) FDA posted an approval letter for ALYFTREK on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALYFTREK | Closed |
Approval Letter PFIZER (Mar 30, 2026) FDA posted an approval letter for CLEOCIN PHOSPHATE on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050441 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN PHOSPHATE | Closed |
Approval Letter NOVARTIS (Mar 30, 2026) FDA posted an approval letter for MEKINIST on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204114, NDA 217513 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MEKINIST | Closed |
Approval Letter NOVARTIS (Mar 30, 2026) FDA posted an approval letter for TAFINLAR on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202806, NDA 217514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAFINLAR | Closed |
Approval Letter AMGEN INC (Mar 30, 2026) FDA posted an approval letter for BKEMV on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BKEMV | Closed |
Approval Letter ARS PHARMS OPERATION (Mar 30, 2026) FDA posted an approval letter for NEFFY on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEFFY | Closed |
Approval Letter PFIZER (Mar 30, 2026) FDA posted an approval letter for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | Closed |
Approval Letter PFIZER (Mar 30, 2026) FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN HYDROCHLORIDE | Closed |
Approval Letter GENENTECH (Mar 30, 2026) FDA posted an approval letter for KADCYLA on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125427 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KADCYLA | Closed |
Approval Letter JANSSEN PHARMS (Mar 27, 2026) FDA posted an approval letter for XARELTO on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022406, NDA 215859 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XARELTO | Closed |
Approval Letter BRISTOL (Mar 27, 2026) FDA posted an approval letter for KRAZATI on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KRAZATI | Closed |
Approval Letter ALKEM LABS LTD (Mar 27, 2026) FDA posted an approval letter for MARINOL on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018651 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MARINOL | Closed |
Approval Letter CORCEPT THERAP (Mar 27, 2026) FDA posted an approval letter for LIFYORLI (COPACKAGED) on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220641 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LIFYORLI (COPACKAGED) | Closed |
Approval Letter PFIZER INC (Mar 27, 2026) FDA posted an approval letter for ELREXFIO on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELREXFIO | Closed |
Approval Letter MERCK SHARP DOHME (Mar 27, 2026) FDA posted an approval letter for WINREVAIR on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WINREVAIR | Closed |
Approval Letter KENVUE BRANDS (Mar 27, 2026) FDA posted an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF | Closed |
Approval Letter OTSUKA ICU MEDCL (Mar 27, 2026) FDA posted an approval letter for RINGER'S IN PLASTIC CONTAINER on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018251 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RINGER'S IN PLASTIC CONTAINER | Closed |
Approval Letter MERZ PHARMS (Mar 25, 2026) FDA posted an approval letter for Xeomin on 2026-03-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA Xeomin | Closed |
Approval Letter LONG GROVE PHARMS (Mar 25, 2026) FDA posted an approval letter for AK-FLUOR 10%, AK-FLUOR 25% on 2026-03-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022186 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AK-FLUOR 10% / AK-FLUOR 25% | Closed |
Approval Letter GLAXOSMITHKLINE (Mar 24, 2026) FDA posted an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-03-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MALARONE / MALARONE PEDIATRIC | Closed |
Approval Letter PH HEALTH (Mar 24, 2026) FDA posted an approval letter for KETALAR on 2026-03-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016812 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KETALAR | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 23, 2026) FDA posted an approval letter for OPUVIZ on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761350 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPUVIZ | Closed |
Approval Letter IMPAX (Mar 23, 2026) FDA posted an approval letter for TWINJECT, ADRENACLICK on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020800 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TWINJECT / ADRENACLICK | Closed |
Approval Letter IMPAX (Mar 23, 2026) FDA posted an approval letter for CREXONT on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217186 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CREXONT | Closed |
Approval Letter IMPAX (Mar 23, 2026) FDA posted an approval letter for RYTARY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203312 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYTARY | Closed |
Approval Letter ORGANON LLC (Mar 23, 2026) FDA posted an approval letter for SINEMET CR on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019856 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SINEMET CR | Closed |
Approval Letter ABBVIE (Mar 23, 2026) FDA posted an approval letter for VYALEV on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216962 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYALEV | Closed |
Approval Letter ADIENNE SA (Mar 23, 2026) FDA posted an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEPADINA / TEPADINA AND SODIUM CHLORIDE | Closed |
Approval Letter ADIENNE SA (Mar 23, 2026) FDA posted an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEPADINA / TEPADINA AND SODIUM CHLORIDE | Closed |
Approval Letter GLAXOSMITHKLINE LLC (Mar 23, 2026) FDA posted an approval letter for MEPRON on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020500 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MEPRON | Closed |
Approval Letter ANNORA PHARMA (Mar 23, 2026) FDA posted an approval letter for DESOGESTREL AND ETHINYL ESTRADIOL on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219761 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DESOGESTREL AND ETHINYL ESTRADIOL | Closed |
Approval Letter ABBVIE (Mar 23, 2026) FDA posted an approval letter for DUOPA on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203952 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUOPA | Closed |
Approval Letter DEPROCO (Mar 23, 2026) FDA posted an approval letter for FLAVALTA on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216564 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLAVALTA | Closed |
Approval Letter ORGANON (Mar 23, 2026) FDA posted an approval letter for SINEMET on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017555 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SINEMET | Closed |
Approval Letter VIATRIS (Mar 23, 2026) FDA posted an approval letter for EPIPEN, EPIPEN JR., EPIPEN E Z PEN on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019430 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPIPEN / EPIPEN JR. / EPIPEN E Z PEN | Closed |
Approval Letter AVION PHARMS (Mar 23, 2026) FDA posted an approval letter for DHIVY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214869 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DHIVY | Closed |
Approval Letter ORION PHARMA (Mar 23, 2026) FDA posted an approval letter for STALEVO 50, STALEVO 100, STALEVO 150 on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021485 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STALEVO 50 / STALEVO 100 / STALEVO 150 | Closed |
Approval Letter ADIENNE SA (Mar 23, 2026) FDA posted an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEPADINA / TEPADINA AND SODIUM CHLORIDE | Closed |
Approval Letter RHYTHM (Mar 23, 2026) FDA posted an approval letter for IMCIVREE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213793 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMCIVREE | Closed |
Approval Letter NOVO (Mar 23, 2026) FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH | Closed |
Approval Letter BRISTOL MYERS SQUIBB (Mar 23, 2026) FDA posted an approval letter for OPDIVO on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OPDIVO | Closed |
Approval Letter GLENMARK SPECLT (Mar 20, 2026) FDA posted an approval letter for FLUTICASONE PROPIONATE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219602 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUTICASONE PROPIONATE | Closed |
Approval Letter GLAXOSMITHKLINE (Mar 20, 2026) FDA posted an approval letter for OJJAARA on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OJJAARA | Closed |
Approval Letter ABBVIE INC (Mar 20, 2026) FDA posted an approval letter for SKYRIZI on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SKYRIZI | Closed |
Approval Letter BRISTOL-MYERS (Mar 20, 2026) FDA posted an approval letter for INREBIC on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA INREBIC | Closed |
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026) FDA posted an approval letter for XTORO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XTORO | Closed |
Approval Letter HARROW EYE (Mar 20, 2026) FDA posted an approval letter for IOPIDINE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019779 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IOPIDINE | Closed |
Approval Letter PROVEPHARM SAS (Mar 20, 2026) FDA posted an approval letter for BAL on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BAL | Closed |
Approval Letter LUNDBECK PHARMS LLC (Mar 20, 2026) FDA posted an approval letter for SABRIL on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020427, NDA 022006 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SABRIL | Closed |
Approval Letter HARROW EYE (Mar 20, 2026) FDA posted an approval letter for IOPIDINE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020258 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IOPIDINE | Closed |
Approval Letter SOBI (Mar 20, 2026) FDA posted an approval letter for VONJO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VONJO | Closed |
Approval Letter GENENTECH (Mar 20, 2026) FDA posted an approval letter for POLIVY on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761121 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POLIVY | Closed |
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026) FDA posted an approval letter for XTORO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XTORO | Closed |
Approval Letter ORGANON (Mar 20, 2026) FDA posted an approval letter for PROSCAR on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020180 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROSCAR | Closed |
Approval Letter VERTEX PHARMS INC (Mar 19, 2026) FDA posted an approval letter for ORKAMBI on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206038, NDA 211358 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ORKAMBI | Closed |
Approval Letter INTERCEPT (Mar 19, 2026) FDA posted an approval letter for LYNAVOY on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220295 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LYNAVOY | Closed |
Approval Letter VERTEX PHARMS INC (Mar 19, 2026) FDA posted an approval letter for ALYFTREK on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALYFTREK | Closed |
Approval Letter PFIZER (Mar 19, 2026) FDA posted an approval letter for NURTEC ODT on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212728 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NURTEC ODT | Closed |
Approval Letter NOVIMMUNE S.A. (Mar 19, 2026) FDA posted an approval letter for GAMIFANT on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761107 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GAMIFANT | Closed |
Approval Letter VERTEX PHARMS (Mar 19, 2026) FDA posted an approval letter for KALYDECO on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203188, NDA 207925 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KALYDECO | Closed |
Approval Letter JANSSEN BIOTECH (Mar 19, 2026) FDA posted an approval letter for ICOTYDE on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220149 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ICOTYDE | Closed |
Approval Letter ABBVIE (Mar 19, 2026) FDA posted an approval letter for COMBIGAN on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021398 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COMBIGAN | Closed |
Approval Letter VERTEX PHARMS INC (Mar 19, 2026) FDA posted an approval letter for TRIKAFTA (COPACKAGED) on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRIKAFTA (COPACKAGED) | Closed |
Approval Letter SANOFI-AVENTIS US (Mar 16, 2026) FDA posted an approval letter for SOLIQUA 100/33 on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 208673 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOLIQUA 100/33 | Closed |
Approval Letter ACCORD HLTHCARE (Mar 16, 2026) FDA posted an approval letter for METHOTREXATE on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214121 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA METHOTREXATE | Closed |
Approval Letter NOVARTIS PHARMS CORP (Mar 16, 2026) FDA posted an approval letter for COSENTYX on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA COSENTYX | Closed |
Approval Letter AM REGENT (Mar 16, 2026) FDA posted an approval letter for VENOFER on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021135 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VENOFER | Closed |
Approval Letter SANOFI-AVENTIS US (Mar 16, 2026) FDA posted an approval letter for ADLYXIN on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 208471 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADLYXIN | Closed |
Approval Letter GILEAD SCIENCES INC (Mar 16, 2026) FDA posted an approval letter for SUNLENCA on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215973, NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUNLENCA | Closed |
Approval Letter BIOMARIN PHARM (Mar 16, 2026) FDA posted an approval letter for PALYNZIQ on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761079 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PALYNZIQ | Closed |
Approval Letter INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC (Mar 16, 2026) FDA posted an approval letter for MEDICAL AIR, USP on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221337 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MEDICAL AIR, USP | Closed |
Approval Letter ELI LILLY AND CO (Mar 16, 2026) FDA posted an approval letter for TRULICITY on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125469 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRULICITY | Closed |
Approval Letter DEXCEL (Mar 12, 2026) FDA posted an approval letter for LANSOPRAZOLE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208025 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LANSOPRAZOLE | Closed |
Approval Letter BAYER (Mar 12, 2026) FDA posted an approval letter for ALEVE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020204 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALEVE | Closed |
Approval Letter SPRINGWORKS (Mar 12, 2026) FDA posted an approval letter for OGSIVEO on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OGSIVEO | Closed |
Approval Letter NEXTWAVE PHARMS (Mar 12, 2026) FDA posted an approval letter for QUILLICHEW ER on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207960 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QUILLICHEW ER | Closed |
Approval Letter KINIKSA PHARMACEUTICALS (UK), LTD. (Mar 12, 2026) FDA posted an approval letter for ARCALYST on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125249 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARCALYST | Closed |
Approval Letter ABBVIE (Mar 12, 2026) FDA posted an approval letter for OZURDEX on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022315 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OZURDEX | Closed |
Approval Letter AYRMID PHARMA (Mar 12, 2026) FDA posted an approval letter for APHEXDA on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217159 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA APHEXDA | Closed |
Approval Letter BAXTER HLTHCARE CORP (Mar 12, 2026) FDA posted an approval letter for DOXIL (LIPOSOMAL) on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050718 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DOXIL (LIPOSOMAL) | Closed |
Approval Letter AYTU (Mar 12, 2026) FDA posted an approval letter for KARBINAL ER on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022556 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KARBINAL ER | Closed |
Approval Letter DEXCEL (Mar 12, 2026) FDA posted an approval letter for OMEPRAZOLE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209400 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OMEPRAZOLE | Closed |
Approval Letter B BRAUN (Mar 10, 2026) FDA posted an approval letter for SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-03-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016733 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Closed |
Approval Letter NEXTWAVE (Mar 10, 2026) FDA posted an approval letter for QUILLIVANT XR on 2026-03-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202100 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QUILLIVANT XR | Closed |
Approval Letter SUPERNUS PHARMS (Mar 9, 2026) FDA posted an approval letter for TROKENDI XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201635 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TROKENDI XR | Closed |
Approval Letter JANSSEN PHARMS (Mar 9, 2026) FDA posted an approval letter for TOPAMAX, TOPAMAX SPRINKLE on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020505, NDA 020844 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TOPAMAX / TOPAMAX SPRINKLE | Closed |
Approval Letter PF PRISM CV (Mar 9, 2026) FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XELJANZ / XELJANZ XR | Closed |
Approval Letter PRAGMA (Mar 9, 2026) FDA posted an approval letter for KEFLEX on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050406 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEFLEX | Closed |
Approval Letter JANSSEN BIOTECH (Mar 9, 2026) FDA posted an approval letter for TALVEY on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TALVEY | Closed |
Approval Letter JANSSEN BIOTECH (Mar 9, 2026) FDA posted an approval letter for TECVAYLI on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761291 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TECVAYLI | Closed |
Approval Letter CHATTEM SANOFI (Mar 9, 2026) FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XYZAL ALLERGY 24HR | Closed |
Approval Letter BRISTOL (Mar 9, 2026) FDA posted an approval letter for SOTYKTU on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOTYKTU | Closed |
Approval Letter VIVUS LLC (Mar 9, 2026) FDA posted an approval letter for QSYMIA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QSYMIA | Closed |
Approval Letter ABBVIE INC (Mar 9, 2026) FDA posted an approval letter for SKYRIZI on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SKYRIZI | Closed |
Approval Letter AZURITY (Mar 9, 2026) FDA posted an approval letter for EPRONTIA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214679 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPRONTIA | Closed |
Approval Letter NOVARTIS (Mar 9, 2026) FDA posted an approval letter for SANDIMMUNE on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050573, NDA 050574, NDA 050625 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SANDIMMUNE | Closed |
Approval Letter UPSHER SMITH LABS (Mar 9, 2026) FDA posted an approval letter for QUDEXY XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205122 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QUDEXY XR | Closed |
Approval Letter JANSSEN BIOTECH (Mar 9, 2026) FDA posted an approval letter for ERLEADA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ERLEADA | Closed |
Approval Letter ASTELLAS (Mar 6, 2026) FDA posted an approval letter for IZERVAY on 2026-03-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217225 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IZERVAY | Closed |
Approval Letter PROVEPHARM SAS (Mar 5, 2026) FDA posted an approval letter for BAL on 2026-03-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BAL | Closed |
Approval Letter PF PRISM CV (Mar 4, 2026) FDA posted an approval letter for BOSULIF on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203341 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BOSULIF | Closed |
Approval Letter ARRAY BIOPHARMA INC (Mar 4, 2026) FDA posted an approval letter for BRAFTOVI on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210496 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRAFTOVI | Closed |
Approval Letter PF PRISM CV (Mar 4, 2026) FDA posted an approval letter for BOSULIF on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217729 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BOSULIF | Closed |
Approval Letter ARRAY BIOPHARMA INC (Mar 4, 2026) FDA posted an approval letter for BRAFTOVI on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210496 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRAFTOVI | Closed |
Approval Letter ACTELION (Mar 4, 2026) FDA posted an approval letter for TRACLEER on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021290, NDA 209279 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TRACLEER | Closed |
Approval Letter ORGANON USA LLC (Mar 4, 2026) FDA posted an approval letter for FOLLISTIM AQ on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 021211 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOLLISTIM AQ | Closed |
Approval Letter HIKMA (Mar 4, 2026) FDA posted an approval letter for ROBINUL on 2026-03-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROBINUL | Closed |
Approval Letter EUGIA PHARMA SPECLTS (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 202668, ANDA 202669 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter SAGENT PHARMS INC (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 203608, ANDA 203609 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter ALEMBIC (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217295, ANDA 217676 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter FRESENIUS KABI USA (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 040278, ANDA 040279 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter NOVO NORDISK INC (Mar 3, 2026) FDA posted an approval letter for SOGROYA on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761156 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SOGROYA | Closed |
Approval Letter MACLEODS PHARMS (Mar 3, 2026) FDA posted an approval letter for DILTIAZEM HYDROCHLORIDE on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218744 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DILTIAZEM HYDROCHLORIDE | Closed |
Approval Letter CUBIST PHARMS LLC (Mar 3, 2026) FDA posted an approval letter for SIVEXTRO on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205435, NDA 205436 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SIVEXTRO | Closed |
Approval Letter ASCENDIS (Mar 3, 2026) FDA posted an approval letter for YUVIWEL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219164 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YUVIWEL | Closed |
Approval Letter KINDOS (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215699, ANDA 216494 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter JANSSEN PRODS (Mar 3, 2026) FDA posted an approval letter for PREZCOBIX PED, PREZCOBIX on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220092 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PREZCOBIX PED / PREZCOBIX | Closed |
Approval Letter INGENUS PHARMS LLC (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 209219, ANDA 209271 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter ACCORD HLTHCARE (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 040743, ANDA 040798 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter CELGENE CORP (Mar 3, 2026) FDA posted an approval letter for REBLOZYL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761136 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REBLOZYL | Closed |
Approval Letter ALMATICA (Mar 3, 2026) FDA posted an approval letter for DULOXETINE HYDROCHLORIDE on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219131 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DULOXETINE HYDROCHLORIDE | Closed |
Approval Letter JAZZ (Mar 3, 2026) FDA posted an approval letter for ZEPZELCA on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPZELCA | Closed |
Approval Letter GLAND (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210123, ANDA 210124 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter HUMANWELL PURACAP (Mar 3, 2026) FDA posted an approval letter for CALCITRIOL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219796 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CALCITRIOL | Closed |
Approval Letter VALEANT LUXEMBOURG (Mar 3, 2026) FDA posted an approval letter for SILIQ on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SILIQ | Closed |
Approval Letter JANSSEN PRODS (Mar 3, 2026) FDA posted an approval letter for PREZCOBIX on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205395 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PREZCOBIX | Closed |
Approval Letter TEVA PHARMS USA (Mar 3, 2026) FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 040333, ANDA 040334 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FLUOROURACIL | Closed |
Approval Letter ARGENX BV (Mar 2, 2026) FDA posted an approval letter for VYVGART HYTRULO on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYVGART HYTRULO | Closed |
Approval Letter GENSCO (Mar 2, 2026) FDA posted an approval letter for RIZAFILM on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIZAFILM | Closed |
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026) FDA posted an approval letter for JASCAYD on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JASCAYD | Closed |
Approval Letter XCOVERY (Mar 2, 2026) FDA posted an approval letter for ENSACOVE on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENSACOVE | Closed |
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026) FDA posted an approval letter for HERNEXEOS on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA HERNEXEOS | Closed |
Approval Letter MERZ PHARMS (Mar 2, 2026) FDA posted an approval letter for Xeomin on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA Xeomin | Closed |
Approval Letter THEA PHARMA (Feb 27, 2026) FDA posted an approval letter for ZIOPTAN on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIOPTAN | Closed |
Approval Letter ELI LILLY AND CO (Feb 27, 2026) FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN | Closed |
Approval Letter NOVO (Feb 27, 2026) FDA posted an approval letter for SAXENDA on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SAXENDA | Closed |
Approval Letter NOVO (Feb 27, 2026) FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH | Closed |
Approval Letter TAKEDA PHARMS USA (Feb 27, 2026) FDA posted an approval letter for ENTYVIO on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125476, BLA 761133 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENTYVIO | Closed |
Approval Letter ETON (Feb 27, 2026) FDA posted an approval letter for DESMODA on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219873 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DESMODA | Closed |
Approval Letter ARS PHARMS OPERATION (Feb 27, 2026) FDA posted an approval letter for NEFFY on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEFFY | Closed |
Approval Letter CHIESI (Feb 27, 2026) FDA posted an approval letter for JUXTAPID on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203858 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JUXTAPID | Closed |
Approval Letter ADC Therapeutics SA (Feb 24, 2026) FDA posted an approval letter for ZYNLONTA on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYNLONTA | Closed |
Approval Letter HERON THERAPS INC (Feb 24, 2026) FDA posted an approval letter for SUSTOL on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022445 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SUSTOL | Closed |
Approval Letter AVYXA HOLDINGS (Feb 24, 2026) FDA posted an approval letter for FAVLYXA on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220201 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FAVLYXA | Closed |
Approval Letter GUERBET (Feb 24, 2026) FDA posted an approval letter for ELUCIREM on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216986 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELUCIREM | Closed |
Approval Letter IMMEDICA PHARMA AB (Feb 24, 2026) FDA posted an approval letter for LOARGYS on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761211 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LOARGYS | Closed |
Approval Letter VANDA PHARMS INC (Feb 24, 2026) FDA posted an approval letter for BYSANTI on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220358 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BYSANTI | Closed |
Approval Letter REGENERON PHARMACEUTICALS (Feb 24, 2026) FDA posted an approval letter for DUPIXENT on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761055 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DUPIXENT | Closed |
Approval Letter REMPEX (Feb 24, 2026) FDA posted an approval letter for VABOMERE on 2026-02-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209776 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VABOMERE | Closed |
Approval Letter ASTRAZENECA (Feb 23, 2026) FDA posted an approval letter for CALQUENCE on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210259, NDA 216387 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CALQUENCE | Closed |
Approval Letter KYOWA KIRIN (Feb 23, 2026) FDA posted an approval letter for POTELIGEO on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761051 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POTELIGEO | Closed |
Approval Letter PF PRISM CV (Feb 23, 2026) FDA posted an approval letter for VFEND on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VFEND | Closed |
Approval Letter PFIZER INC (Feb 23, 2026) FDA posted an approval letter for ELREXFIO on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ELREXFIO | Closed |
Approval Letter ABBVIE (Feb 23, 2026) FDA posted an approval letter for VENCLEXTA on 2026-02-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208573 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VENCLEXTA | Closed |
Approval Letter GENENTECH INC (Feb 20, 2026) FDA posted an approval letter for EVRYSDI on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213535, NDA 219285 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EVRYSDI | Closed |
Approval Letter HIKMA (Feb 20, 2026) FDA posted an approval letter for ROBINUL on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017558 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROBINUL | Closed |
Approval Letter JANSSEN BIOTECH (Feb 20, 2026) FDA posted an approval letter for RYBREVANT FASPRO on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761484 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYBREVANT FASPRO | Closed |
Approval Letter GENERAL AIR SERVICE & SUPPLY COMPANY (Feb 20, 2026) FDA posted an approval letter for AIR on 2026-02-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221287 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AIR | Closed |
Approval Letter SCIENTURE (Feb 19, 2026) FDA posted an approval letter for ARBLI on 2026-02-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218772 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ARBLI | Closed |
Approval Letter RIDGEBACK BIOTHERAPEUTICS (Feb 19, 2026) FDA posted an approval letter for EBANGA on 2026-02-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761172 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EBANGA | Closed |
Approval Letter FRESENIUS KABI USA (Feb 19, 2026) FDA posted an approval letter for DIPRIVAN on 2026-02-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019627 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIPRIVAN | Closed |
Approval Letter VIATRIS (Feb 19, 2026) FDA posted an approval letter for REVATIO on 2026-02-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022473, NDA 021845 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REVATIO | Closed |
Approval Letter HQ SPCLT PHARMA (Feb 18, 2026) FDA posted an approval letter for CEFAZOLIN SODIUM on 2026-02-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211413 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEFAZOLIN SODIUM | Closed |
Approval Letter BAYER HLTHCARE (Feb 18, 2026) FDA posted an approval letter for EOVIST, GADAVIST on 2026-02-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022090, NDA 201277 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EOVIST / GADAVIST | Closed |
Approval Letter AVYXA HOLDINGS (Feb 18, 2026) FDA posted an approval letter for AVOPEF on 2026-02-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220200 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVOPEF | Closed |
Approval Letter HARMONY (Feb 18, 2026) FDA posted an approval letter for WAKIX on 2026-02-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211150 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WAKIX | Closed |
Approval Letter AOP HLTH US (Feb 18, 2026) FDA posted an approval letter for RAPIBLYK on 2026-02-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217202 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RAPIBLYK | Closed |
Approval Letter PFIZER (Feb 13, 2026) FDA posted an approval letter for CLEOCIN PHOSPHATE, CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050441, NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN PHOSPHATE / CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER | Closed |
Approval Letter JANSSEN BIOTECH (Feb 13, 2026) FDA posted an approval letter for DARZALEX FASPRO on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DARZALEX FASPRO | Closed |
Approval Letter PFIZER (Feb 13, 2026) FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLEOCIN HYDROCHLORIDE | Closed |
Approval Letter ACROTECH BIOPHARMA (Feb 13, 2026) FDA posted an approval letter for ADQUEY on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219474 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ADQUEY | Closed |
Approval Letter KENVUE BRANDS (Feb 13, 2026) FDA posted an approval letter for PEPCID AC on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020325 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PEPCID AC | Closed |
Approval Letter ACCORD (Feb 13, 2026) FDA posted an approval letter for CAMCEVI KIT on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211488 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAMCEVI KIT | Closed |
Approval Letter NOVARTIS (Feb 13, 2026) FDA posted an approval letter for LEQVIO on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEQVIO | Closed |
Approval Letter MAYNE PHARMA (Feb 12, 2026) FDA posted an approval letter for BIJUVA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210132 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BIJUVA | Closed |
Approval Letter MERCK SHARP DOHME (Feb 12, 2026) FDA posted an approval letter for KEYTRUDA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA | Closed |
Approval Letter MERCK SHARP DOHME (Feb 12, 2026) FDA posted an approval letter for KEYTRUDA QLEX on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA KEYTRUDA QLEX | Closed |
Approval Letter VERTICAL PHARMS (Feb 12, 2026) FDA posted an approval letter for DIVIGEL on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022038 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIVIGEL | Closed |
Approval Letter SANOFI AVENTIS US (Feb 12, 2026) FDA posted an approval letter for AUBAGIO on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202992 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AUBAGIO | Closed |
Approval Letter ASPEN (Feb 12, 2026) FDA posted an approval letter for CENESTIN on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020992 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CENESTIN | Closed |
Approval Letter ACERTIS PHARMS (Feb 12, 2026) FDA posted an approval letter for PROMETRIUM on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019781 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PROMETRIUM | Closed |
Approval Letter ASPEN (Feb 12, 2026) FDA posted an approval letter for ENJUVIA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021443 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENJUVIA | Closed |
Approval Letter PFIZER (Feb 12, 2026) FDA posted an approval letter for PAXLOVID (COPACKAGED) on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217188 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PAXLOVID (COPACKAGED) | Closed |
Approval Letter EMERGENT (Feb 12, 2026) FDA posted an approval letter for NARCAN on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208411 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NARCAN | Closed |
Approval Letter PFIZER (Feb 12, 2026) FDA posted an approval letter for ESTRING on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020472 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ESTRING | Closed |
Approval Letter SANDOZ INC (Feb 12, 2026) FDA posted an approval letter for ENZEEVU on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761382 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENZEEVU | Closed |
Approval Letter ALKEM LABS LTD (Feb 11, 2026) FDA posted an approval letter for MIRABEGRON on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219323 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MIRABEGRON | Closed |
Approval Letter EPIC PHARMA LLC (Feb 11, 2026) FDA posted an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214378 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAPENTADOL HYDROCHLORIDE | Closed |
Approval Letter GLAND (Feb 11, 2026) FDA posted an approval letter for BORTEZOMIB on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219167 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BORTEZOMIB | Closed |
Approval Letter NOVAST LABS (Feb 11, 2026) FDA posted an approval letter for CONJUGATED ESTROGENS on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214025 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CONJUGATED ESTROGENS | Closed |
Approval Letter NOVAST LABS (Feb 11, 2026) FDA posted an approval letter for CONJUGATED ESTROGENS on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214023 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CONJUGATED ESTROGENS | Closed |
Approval Letter NOVITIUM PHARMA (Feb 11, 2026) FDA posted an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219119 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TAPENTADOL HYDROCHLORIDE | Closed |
Approval Letter MANKIND PHARMA (Feb 11, 2026) FDA posted an approval letter for TICAGRELOR on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217679 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TICAGRELOR | Closed |
Approval Letter SUN PHARM INDS INC (Feb 10, 2026) FDA posted an approval letter for ABSORICA, ABSORICA LD on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABSORICA / ABSORICA LD | Closed |
Approval Letter HIKMA (Feb 10, 2026) FDA posted an approval letter for REGLAN on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017862 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REGLAN | Closed |
Approval Letter ANI PHARMS (Feb 10, 2026) FDA posted an approval letter for REGLAN on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017854 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA REGLAN | Closed |
Approval Letter QOL MEDCL (Feb 10, 2026) FDA posted an approval letter for GIMOTI on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209388 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GIMOTI | Closed |
Approval Letter BAXTER HLTHCARE CORP (Feb 9, 2026) FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-02-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214313 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE / NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | Closed |
Approval Letter CYTOKINETICS (Feb 6, 2026) FDA posted an approval letter for MYQORZO on 2026-02-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219083 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MYQORZO | Closed |
Approval Letter PFIZER (Feb 6, 2026) FDA posted an approval letter for IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE on 2026-02-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050734 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE | Closed |
Approval Letter XTTRIUM (Feb 5, 2026) FDA posted an approval letter for DYNA-HEX 2 on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DYNA-HEX 2 | Closed |
Approval Letter RADIUS (Feb 5, 2026) FDA posted an approval letter for BINOSTO on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202344 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BINOSTO | Closed |
Approval Letter ORGANON (Feb 5, 2026) FDA posted an approval letter for FOSAMAX on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020560 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOSAMAX | Closed |
Approval Letter ORGANON LLC (Feb 5, 2026) FDA posted an approval letter for FOSAMAX PLUS D on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021762 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FOSAMAX PLUS D | Closed |
Approval Letter AVYXA HOLDINGS (Feb 5, 2026) FDA posted an approval letter for VYKOURA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220406 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYKOURA | Closed |
Approval Letter BAYER HLTHCARE (Feb 5, 2026) FDA posted an approval letter for STIVARGA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203085 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA STIVARGA | Closed |
Approval Letter APIL (Feb 5, 2026) FDA posted an approval letter for ACTONEL on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020835 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ACTONEL | Closed |
Approval Letter APIL (Feb 5, 2026) FDA posted an approval letter for ATELVIA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022560 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ATELVIA | Closed |
Approval Letter SANDOZ (Feb 5, 2026) FDA posted an approval letter for RECLAST on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021817 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RECLAST | Closed |
Approval Letter XTTRIUM (Feb 5, 2026) FDA posted an approval letter for DYNA-HEX 4 on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DYNA-HEX 4 | Closed |
Approval Letter ACCORD HLTHCARE (Feb 5, 2026) FDA posted an approval letter for ATROPINE SULFATE on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214652 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ATROPINE SULFATE | Closed |
Approval Letter GILEAD SCIENCES INC (Feb 3, 2026) FDA posted an approval letter for LIVDELZI on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217899 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LIVDELZI | Closed |
Approval Letter APOTEX (Feb 3, 2026) FDA posted an approval letter for EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214095 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE | Closed |
Approval Letter ALKERMES INC (Feb 3, 2026) FDA posted an approval letter for LYBALVI on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213378 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LYBALVI | Closed |
Approval Letter CHEPLAPHARM (Feb 3, 2026) FDA posted an approval letter for ZYPREXA, ZYPREXA ZYDIS, ZYPREXA RELPREVV on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020592, NDA 021086, NDA 021253, NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYPREXA / ZYPREXA ZYDIS / ZYPREXA RELPREVV | Closed |
Approval Letter NOVO (Feb 3, 2026) FDA posted an approval letter for RYBELSUS, OZEMPIC on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213051 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYBELSUS / OZEMPIC | Closed |
Approval Letter IMMUNEX (Feb 3, 2026) FDA posted an approval letter for ENBREL on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103795 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENBREL | Closed |
Approval Letter BIONPHARMA (Feb 3, 2026) FDA posted an approval letter for CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE HIVES RELIEF on 2026-02-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022429 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CETIRIZINE HYDROCHLORIDE ALLERGY / CETIRIZINE HYDROCHLORIDE HIVES RELIEF | Closed |
Approval Letter GENSCO (Jan 30, 2026) FDA posted an approval letter for RIZAFILM on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RIZAFILM | Closed |
Approval Letter PFIZER (Jan 30, 2026) FDA posted an approval letter for LORBRENA on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210868 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LORBRENA | Closed |
Approval Letter NOVO (Jan 30, 2026) FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH | Closed |
Approval Letter JOURNEY (Jan 30, 2026) FDA posted an approval letter for XIMINO on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201922 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA XIMINO | Closed |
Approval Letter OTSUKA PHARM CO LTD (Jan 29, 2026) FDA posted an approval letter for ABILIFY MAINTENA KIT on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202971 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ABILIFY MAINTENA KIT | Closed |
Approval Letter PF PRISM CV (Jan 29, 2026) FDA posted an approval letter for VFEND on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VFEND | Closed |
Approval Letter VISUS (Jan 29, 2026) FDA posted an approval letter for YUVEZZI on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220142 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YUVEZZI | Closed |
Approval Letter GLAUKOS (Jan 28, 2026) FDA posted an approval letter for IDOSE TR on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218010 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDOSE TR | Closed |
Approval Letter JAZZ PHARMS THERAP (Jan 28, 2026) FDA posted an approval letter for VYXEOS on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209401 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VYXEOS | Closed |
Approval Letter GENZYME CORP (Jan 28, 2026) FDA posted an approval letter for CAPRELSA on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022405 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CAPRELSA | Closed |
Approval Letter SANOFI AVENTIS US (Jan 28, 2026) FDA posted an approval letter for PRIFTIN on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021024 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PRIFTIN | Closed |
Approval Letter JANSSEN BIOTECH (Jan 28, 2026) FDA posted an approval letter for DARZALEX FASPRO on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761145 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DARZALEX FASPRO | Closed |
Approval Letter GLAUKOS (Jan 28, 2026) FDA posted an approval letter for IDOSE TR on 2026-01-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218010 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IDOSE TR | Closed |
Approval Letter SCHERING (Jan 27, 2026) FDA posted an approval letter for NOXAFIL, NOXAFIL POWDERMIX KIT on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022003, NDA 205053, NDA 205596, NDA 214770 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NOXAFIL / NOXAFIL POWDERMIX KIT | Closed |
Approval Letter SOLUBIOMIX (Jan 27, 2026) FDA posted an approval letter for QUIOFIC on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216395 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA QUIOFIC | Closed |
Approval Letter AVION PHARMS (Jan 27, 2026) FDA posted an approval letter for PONSTEL on 2026-01-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 015034 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PONSTEL | Closed |
Approval Letter MANNKIND (Jan 26, 2026) FDA posted an approval letter for AFREZZA on 2026-01-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AFREZZA | Closed |
Approval Letter SAMSUNG BIOEPIS CO LTD (Jan 26, 2026) FDA posted an approval letter for EPYSQLI on 2026-01-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EPYSQLI | Closed |
Approval Letter VERTEX PHARMS INC (Jan 26, 2026) FDA posted an approval letter for JOURNAVX on 2026-01-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219209 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA JOURNAVX | Closed |
Approval Letter APOTEX (Jan 26, 2026) FDA posted an approval letter for CALDOLOR on 2026-01-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022348 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CALDOLOR | Closed |
Approval Letter JANSSEN PHARMS (Jan 26, 2026) FDA posted an approval letter for SPRAVATO on 2026-01-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SPRAVATO | Closed |
Approval Letter SHORLA (Jan 23, 2026) FDA posted an approval letter for TEPYLUTE on 2026-01-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216984 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TEPYLUTE | Closed |
Approval Letter UCB INC (Jan 23, 2026) FDA posted an approval letter for ZILBRYSQ on 2026-01-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216834 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZILBRYSQ | Closed |
Approval Letter TG THERAPEUTICS, INC (Jan 22, 2026) FDA posted an approval letter for BRIUMVI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761238 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BRIUMVI | Closed |
Approval Letter B BRAUN (Jan 22, 2026) FDA posted an approval letter for POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019708 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER / POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Closed |
Approval Letter MSD (Jan 22, 2026) FDA posted an approval letter for VERQUVO on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214377 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA VERQUVO | Closed |
Approval Letter SHANDONG LUYE (Jan 22, 2026) FDA posted an approval letter for RYKINDO on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212849 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA RYKINDO | Closed |
Approval Letter GENENTECH INC (Jan 22, 2026) FDA posted an approval letter for EVRYSDI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219285, NDA 213535 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA EVRYSDI | Closed |
Approval Letter FRESENIUS KABI USA (Jan 22, 2026) FDA posted an approval letter for TYENNE on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA TYENNE | Closed |
Approval Letter ADC Therapeutics SA (Jan 22, 2026) FDA posted an approval letter for ZYNLONTA on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761196 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYNLONTA | Closed |
Approval Letter ORGANON (Jan 22, 2026) FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IMPLANON / NEXPLANON | Closed |
Approval Letter EISAI INC (Jan 22, 2026) FDA posted an approval letter for LEQEMBI on 2026-01-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761269 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LEQEMBI | Closed |
Approval Letter BAUSCH AND LOMB (Jan 21, 2026) FDA posted an approval letter for ZIRGAN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022211 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZIRGAN | Closed |
Approval Letter ALEMBIC (Jan 21, 2026) FDA posted an approval letter for LOTEPREDNOL ETABONATE AND TOBRAMYCIN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217597 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LOTEPREDNOL ETABONATE AND TOBRAMYCIN | Closed |
Approval Letter ELI LILLY AND CO (Jan 21, 2026) FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN | Closed |
Approval Letter ELI LILLY AND CO (Jan 21, 2026) FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-01-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN | Closed |
Approval Letter TEVA PHARMS INC (Jan 20, 2026) FDA posted an approval letter for ALVAIZ on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216774 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ALVAIZ | Closed |
Approval Letter FRESENIUS KABI USA (Jan 20, 2026) FDA posted an approval letter for OTULFI on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761379 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA OTULFI | Closed |
Approval Letter ACCORD BIOPHARMA INC. (Jan 20, 2026) FDA posted an approval letter for FILKRI on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761027 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA FILKRI | Closed |
Approval Letter BIONPHARMA (Jan 20, 2026) FDA posted an approval letter for NAPROXEN SODIUM on 2026-01-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021920 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NAPROXEN SODIUM | Closed |
Approval Letter ESPERION THERAPS INC (Jan 16, 2026) FDA posted an approval letter for NEXLETOL on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211616 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEXLETOL | Closed |
Approval Letter ESPERION THERAPS INC (Jan 16, 2026) FDA posted an approval letter for NEXLIZET on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211617 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NEXLIZET | Closed |
Approval Letter EMERGENT (Jan 16, 2026) FDA posted an approval letter for NARCAN on 2026-01-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208411 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA NARCAN | Closed |
Approval Letter CELLTRION INC (Jan 15, 2026) FDA posted an approval letter for AVTOZMA on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AVTOZMA | Closed |
Approval Letter NOVARTIS (Jan 15, 2026) FDA posted an approval letter for GLEEVEC on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA GLEEVEC | Closed |
Approval Letter KENVUE BRANDS (Jan 15, 2026) FDA posted an approval letter for ROGAINE (FOR MEN), ROGAINE (FOR WOMEN), ROGAINE EXTRA STRENGTH (FOR MEN) on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019501, NDA 020834, NDA 021812 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ROGAINE (FOR MEN) / ROGAINE (FOR WOMEN) / ROGAINE EXTRA STRENGTH (FOR MEN) | Closed |
Approval Letter BIOCON BIOLOGICS INC (Jan 15, 2026) FDA posted an approval letter for YESAFILI on 2026-01-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761274 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YESAFILI | Closed |
Approval Letter GENZYME (Jan 13, 2026) FDA posted an approval letter for CEREZYME on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 020367 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CEREZYME | Closed |
Approval Letter ZYDUS (Jan 13, 2026) FDA posted an approval letter for DIROXIMEL FUMARATE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218596 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIROXIMEL FUMARATE | Closed |
Approval Letter AMNEAL (Jan 13, 2026) FDA posted an approval letter for IOHEXOL on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217737 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA IOHEXOL | Closed |
Approval Letter COSETTE PHARMS NC (Jan 13, 2026) FDA posted an approval letter for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218273 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE | Closed |
Approval Letter AUROBINDO PHARMA LTD (Jan 13, 2026) FDA posted an approval letter for PSEUDOEPHEDRINE HYDROCHLORIDE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218854 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA PSEUDOEPHEDRINE HYDROCHLORIDE | Closed |
Approval Letter SANDOZ (Jan 13, 2026) FDA posted an approval letter for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 202388 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | Closed |
Approval Letter APOTEX (Jan 13, 2026) FDA posted an approval letter for CLADRIBINE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218425 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA CLADRIBINE | Closed |
Approval Letter NAVINTA LLC (Jan 13, 2026) FDA posted an approval letter for DIAZEPAM on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217468 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA DIAZEPAM | Closed |
Approval Letter WATSON LABS INC (Jan 13, 2026) FDA posted an approval letter for SITAGLIPTIN PHOSPHATE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 202327 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA SITAGLIPTIN PHOSPHATE | Closed |
Approval Letter MYLAN (Jan 13, 2026) FDA posted an approval letter for LINAGLIPTIN on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208431 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA LINAGLIPTIN | Closed |
Approval Letter TEVA PHARMS USA INC (Jan 13, 2026) FDA posted an approval letter for ESTRADIOL on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214137 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ESTRADIOL | Closed |
Approval Letter AMNEAL IRELAND LTD (Jan 13, 2026) FDA posted an approval letter for BECLOMETHASONE DIPROPIONATE on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213811 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA BECLOMETHASONE DIPROPIONATE | Closed |
Approval Letter SENTYNL THERAPS INC (Jan 13, 2026) FDA posted an approval letter for ZYCUBO on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211241 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZYCUBO | Closed |
Approval Letter XCOVERY (Jan 9, 2026) FDA posted an approval letter for ENSACOVE on 2026-01-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ENSACOVE | Closed |
Approval Letter ELI LILLY AND CO (Jan 8, 2026) FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN | Closed |
Approval Letter SAREPTA THERAPS INC (Jan 8, 2026) FDA posted an approval letter for AMONDYS 45 on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213026 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA AMONDYS 45 | Closed |
Approval Letter BIOCON BIOLOGICS INC (Jan 8, 2026) FDA posted an approval letter for YESINTEK on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761406 as an original application. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA YESINTEK | Closed |
Approval Letter ELI LILLY AND CO (Jan 8, 2026) FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | AL | Posted by FDA | US FDA MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN | Closed |