FDA letters by response type
Tentative Approval Letter FDA Letters
Application meets requirements but marketing is blocked (patent/exclusivity). Browse source-linked tentative approval letter records with structured metadata, regulatory context, and document-level summaries.
| Letter | Type | Date | Agency / Product | Status |
|---|---|---|---|---|
Tentative Approval Letter LUPIN (Sep 29, 2026) FDA posted a tentative approval letter for APIXABAN on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220446 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA APIXABAN | Closed |
Tentative Approval Letter TEVA PHARM (Sep 4, 2026) FDA posted a tentative approval letter for SHEUR on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217650 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA SHEUR | Closed |
Tentative Approval Letter SANDOZ INC (Sep 4, 2026) FDA posted a tentative approval letter for RELUGOLIX on 2026-09-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219913 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA RELUGOLIX | Closed |
Tentative Approval Letter SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD (Aug 25, 2026) FDA posted a tentative approval letter for NDA 218328 on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218328 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA NDA 218328 | Closed |
Tentative Approval Letter CMG PHARM CO LTD (Aug 4, 2026) FDA posted a tentative approval letter for MEZOFY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211448 as a supplement. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA MEZOFY | Closed |
Tentative Approval Letter APOTEX (Aug 3, 2026) FDA posted a tentative approval letter for Ruxolitinib on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219660 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA Ruxolitinib | Closed |
Tentative Approval Letter TEVA PHARMS USA (Jul 24, 2026) FDA posted a tentative approval letter for CANAGLIFLOZIN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210451 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA CANAGLIFLOZIN | Closed |
Tentative Approval Letter AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD (Jul 22, 2026) FDA posted a tentative approval letter for ANDA 220197 on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220197 | Closed |
Tentative Approval Letter MSN (Jul 22, 2026) FDA posted a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA BOSUTINIB MONOHYDRATE / BOSUTINIB | Closed |
Tentative Approval Letter AFT PHARMACEUTICALS LTD (Jul 22, 2026) FDA posted a tentative approval letter for SCOMARA on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA SCOMARA | Closed |
Tentative Approval Letter APOTEX INC (Jul 22, 2026) FDA posted a tentative approval letter for RUXOLITINIB on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA RUXOLITINIB | Closed |
Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 22, 2026) FDA posted a tentative approval letter for UBROGEPANT on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA UBROGEPANT | Closed |
Tentative Approval Letter MSN LABORATORIES PRIVATE LIMITED (Jul 21, 2026) FDA posted a tentative approval letter for UBROGEPANT on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA UBROGEPANT | Closed |
Tentative Approval Letter ALEMBIC PHARMACEUTICALS LIMITED (Jul 21, 2026) FDA posted a tentative approval letter for LAROTRECTINIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA LAROTRECTINIB | Closed |
Tentative Approval Letter SANDOZ INC (Jul 21, 2026) FDA posted a tentative approval letter for TIVOZANIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA TIVOZANIB | Closed |
Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026) FDA posted a tentative approval letter for ANDA 220143 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220143 | Closed |
Tentative Approval Letter REGCON HOLDINGS (Jul 21, 2026) FDA posted a tentative approval letter for CEFTRIAXONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA CEFTRIAXONE | Closed |
Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 21, 2026) FDA posted a tentative approval letter for ANDA 220724 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220724 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220724 | Closed |
Tentative Approval Letter TEVA PHARMACEUTICALS, INC. (Jul 21, 2026) FDA posted a tentative approval letter for ANDA 219413 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219413 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 219413 | Closed |
Tentative Approval Letter SANDOZ INC (Jul 21, 2026) FDA posted a tentative approval letter for PEMIGATINIB on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA PEMIGATINIB | Closed |
Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026) FDA posted a tentative approval letter for ANDA 220866 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220866 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220866 | Closed |
Tentative Approval Letter SANDOZ INC (Jul 21, 2026) FDA posted a tentative approval letter for ANDA 219346 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219346 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 219346 | Closed |
Tentative Approval Letter AZURITY PHARMACEUTICALS INC (Jul 21, 2026) FDA posted a tentative approval letter for EDARAVONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA EDARAVONE | Closed |
Tentative Approval Letter AZURITY (Jul 2, 2026) FDA posted a tentative approval letter for ABANTA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221024 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ABANTA | Closed |
Tentative Approval Letter NOVITIUM PHARMA (Jun 9, 2026) FDA posted a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA PITOLISANT HYDROCHLORIDE | Closed |
Tentative Approval Letter INVENTIA HEALTHCARE LIMITED (Jun 9, 2026) FDA posted a tentative approval letter for ANDA 218760 on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218760 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 218760 | Closed |
Tentative Approval Letter ALKEM LABS LTD (Jun 9, 2026) FDA posted a combined approval and tentative 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 211563 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Closed |
Tentative Approval Letter TARO PHARMACEUTICALS INC (Jun 9, 2026) FDA posted a tentative approval letter for ANDA 212211 on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212211 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 212211 | Closed |
Tentative Approval Letter APOTEX INC (Jun 8, 2026) FDA posted a tentative approval letter for ANDA 220169 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220169 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220169 | Closed |
Tentative Approval Letter ASCENT PHARMACEUTICALS INC. (Jun 8, 2026) FDA posted a tentative approval letter for ANDA 220025 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220025 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220025 | Closed |
Tentative Approval Letter APPCO PHARMA LLC (Jun 8, 2026) FDA posted a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA VILOXAZINE HYDROCHLORIDE | Closed |
Tentative Approval Letter CHANGZHOU PHARMACEUTICAL FACTORY (Jun 8, 2026) FDA posted a tentative approval letter for VERICIGUAT on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA VERICIGUAT | Closed |
Tentative Approval Letter TORRENT PHARMACEUTICALS LTD (Jun 8, 2026) FDA posted a tentative approval letter for VERICIGUAT on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA VERICIGUAT | Closed |
Tentative Approval Letter ANNORA PHARMA PRIVATE LIMITED (Jun 8, 2026) FDA posted a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA GABAPENTIN ENACARBIL | Closed |
Tentative Approval Letter ALKEM LABORATORIES LIMITED (Jun 8, 2026) FDA posted a tentative approval letter for ANDA 220352 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220352 | Closed |
Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 5, 2026) FDA posted a tentative approval letter for CENOBAMATE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219473 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA CENOBAMATE | Closed |
Tentative Approval Letter HETERO LABS LIMITED (Jun 5, 2026) FDA posted a tentative approval letter for CYCLOPHOSPHAMIDE on 2026-06-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219271 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA CYCLOPHOSPHAMIDE | Closed |
Tentative Approval Letter LANTHEUS MEDICAL (Jun 2, 2026) FDA posted a tentative approval letter for BRAVNETSA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217060 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA BRAVNETSA | Closed |
Tentative Approval Letter MACLEODS PHARMS (Jun 2, 2026) FDA posted a tentative approval letter for MILNACIPRAN HYDROCHLORIDE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210944 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA MILNACIPRAN HYDROCHLORIDE | Closed |
Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 2, 2026) FDA posted a tentative approval letter for ANDA 217786 on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217786 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 217786 | Closed |
Tentative Approval Letter MANKIND PHARMA (Jun 2, 2026) FDA posted a tentative approval letter for ANDA 212283 on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212283 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 212283 | Closed |
Tentative Approval Letter ALKEM LABS LTD (Jun 2, 2026) FDA posted a tentative approval letter for SITAGLIPTIN PHOSPHATE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215155 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA SITAGLIPTIN PHOSPHATE | Closed |
Tentative Approval Letter RENATA LIMITED (May 26, 2026) FDA posted a tentative approval letter for ANDA 219257 on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219257 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 219257 | Closed |
Tentative Approval Letter ASPEN SA OPERATIONS (PTY) LTD (May 5, 2026) FDA posted a tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on 2026-05-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219804 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE | Closed |
Tentative Approval Letter AMNEAL PHARMS NY (Mar 23, 2026) FDA posted a tentative approval letter for KITPROZY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220712 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA KITPROZY | Closed |
Tentative Approval Letter APPCO PHARMA LLC (Mar 20, 2026) FDA posted a tentative approval letter for ANDA 220327 on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220327 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220327 | Closed |
Tentative Approval Letter APOTEX INC (Mar 20, 2026) FDA posted a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | Closed |
Tentative Approval Letter NATCO PHARMA LTD (Mar 20, 2026) FDA posted a tentative approval letter for ERDAFITINIB on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218578 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ERDAFITINIB | Closed |
Tentative Approval Letter AMNEAL (Mar 19, 2026) FDA posted a tentative approval letter for MACITENTAN on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211000 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA MACITENTAN | Closed |
Tentative Approval Letter MSN PHARMACEUTICALS INC (Mar 19, 2026) FDA posted a tentative approval letter for AFATINIB on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA AFATINIB | Closed |
Tentative Approval Letter RUBICON RESEARCH PRIVATE LIMITED (Feb 11, 2026) FDA posted a tentative approval letter for ANDA 219440 on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219440 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 219440 | Closed |
Tentative Approval Letter AUROBINDO PHARMA (Feb 11, 2026) FDA posted a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA GLYCEROL PHENYLBUTYRATE | Closed |
Tentative Approval Letter MYLAN PHARMACEUTICALS INC (Feb 11, 2026) FDA posted a tentative approval letter for RIFAXIMIN on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA RIFAXIMIN | Closed |
Tentative Approval Letter BPI LABS LLC (Feb 11, 2026) FDA posted a tentative approval letter for SELENIOUS ACID on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220051 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA SELENIOUS ACID | Closed |
Tentative Approval Letter HETERO LABS LIMITED (Feb 11, 2026) FDA posted a tentative approval letter for ANDA 220525 on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220525 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA ANDA 220525 | Closed |
Tentative Approval Letter GRANULES PHARMACEUTICALS INC (Feb 11, 2026) FDA posted a tentative approval letter for AMPHETAMINE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220284 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA AMPHETAMINE | Closed |
Tentative Approval Letter APOTEX CORP (Jan 13, 2026) FDA posted a tentative approval letter for RIMEGEPANT on 2026-01-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219399 as an original application. Review the exact FDA letter for the approved conditions and labeling. | TA | Posted by FDA | US FDA RIMEGEPANT | Closed |