FDA Letters Issued in 2026

FDA issued an approval letter for AVAPRO on 2026-07-28. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for GARZULYS on 2026-07-28. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LYTENAVA on 2026-07-28. The source metadata identifies BLA 761320 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DYNA-HEX 2 on 2026-07-28. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DYNA-HEX 4 on 2026-07-28. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REZDIFFRA on 2026-07-28. The source metadata identifies NDA 217785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BREXAFEMME on 2026-07-28. The source metadata identifies NDA 214900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SIMTRIYO on 2026-07-28. The source metadata identifies NDA 218145 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IDKIT:HP on 2026-07-28. The source metadata identifies NDA 021314 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZIAC on 2026-07-28. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XTANDI on 2026-07-28. The source metadata identifies NDA 203415, NDA 213674 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NORVIR on 2026-07-27. The source metadata identifies NDA 022417, NDA 209512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MACRILEN on 2026-07-27. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TYRUKO on 2026-07-27. The source metadata identifies BLA 761322 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KALETRA on 2026-07-27. The source metadata identifies NDA 021906, NDA 021251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for JIDEYTRO on 2026-07-24. The source metadata identifies NDA 220185 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REVLIMID on 2026-07-24. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S MOTRIN on 2026-07-24. The source metadata identifies NDA 020516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NEURACEQ on 2026-07-24. The source metadata identifies NDA 204677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CANAGLIFLOZIN on 2026-07-24. The source metadata identifies ANDA 210451 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CAMCEVI ETM on 2026-07-23. The source metadata identifies NDA 219745 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ACANYA, ONEXTON on 2026-07-23. The source metadata identifies NDA 050819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Eherbs Imports, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 217769 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for JAKAFI, JAKAFI XR on 2026-07-22. The source metadata identifies NDA 202192, NDA 217180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220197 on 2026-07-22. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 218016 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FOSTAMATINIB DISODIUM on 2026-07-22. The source metadata identifies ANDA 217329 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VASOPRESSIN on 2026-07-22. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROMIDEPSIN on 2026-07-22. The source metadata identifies ANDA 219099 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 219165 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for SCOMARA on 2026-07-22. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INREBIC on 2026-07-22. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VONJO on 2026-07-22. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 217076 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for RUXOLITINIB on 2026-07-22. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OJJAARA on 2026-07-22. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 212572 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VENETOCLAX on 2026-07-22. The source metadata identifies ANDA 214733 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 218722 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for UBROGEPANT on 2026-07-22. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a tentative approval letter for UBROGEPANT on 2026-07-21. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for LAROTRECTINIB on 2026-07-21. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for TIVOZANIB on 2026-07-21. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220143 on 2026-07-21. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CEFTRIAXONE on 2026-07-21. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220724 on 2026-07-21. The source metadata identifies ANDA 220724 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219413 on 2026-07-21. The source metadata identifies ANDA 219413 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for PEMIGATINIB on 2026-07-21. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPINEPHRINE on 2026-07-21. The source metadata identifies ANDA 220562 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SUBVENITE on 2026-07-21. The source metadata identifies NDA 218879 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZOLPIDEM TARTRATE on 2026-07-21. The source metadata identifies ANDA 220717 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AUGMENTIN '125', AUGMENTIN '250', AUGMENTIN '200' on 2026-07-21. 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.

FDA issued an approval letter for GALLIUM GA 68 GOZETOTIDE on 2026-07-21. The source metadata identifies ANDA 219189 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRAMADOL HYDROCHLORIDE on 2026-07-21. The source metadata identifies ANDA 219647 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220866 on 2026-07-21. The source metadata identifies ANDA 220866 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ADRENALIN on 2026-07-21. The source metadata identifies NDA 204640 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 219346 on 2026-07-21. The source metadata identifies ANDA 219346 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OGSIVEO on 2026-07-21. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for EDARAVONE on 2026-07-21. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LEQEMBI IQLIK on 2026-07-20. The source metadata identifies BLA 761375 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FABHALTA on 2026-07-20. The source metadata identifies NDA 218276 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BUPRENORPHINE HYDROCHLORIDE on 2026-07-20. The source metadata identifies ANDA 090279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN on 2026-07-20. The source metadata identifies NDA 201811 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ZYRTEC HIVES, CHILDREN'S ZYRTEC ALLERGY on 2026-07-20. The source metadata identifies NDA 022155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NEUPOGEN on 2026-07-20. The source metadata identifies BLA 103353 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for GLEEVEC on 2026-07-20. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ILUMYA on 2026-07-20. The source metadata identifies BLA 761067 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IC-GREEN on 2026-07-20. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050710, NDA 050784, NDA 050711 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PURIXAN on 2026-07-20. The source metadata identifies NDA 205919 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VERZENIO on 2026-07-20. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REZZAYO on 2026-07-20. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PHEBURANE on 2026-07-20. The source metadata identifies NDA 216513 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to mkpodplug.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for STELARA on 2026-07-16. The source metadata identifies BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LIPFENDRA on 2026-07-16. The source metadata identifies NDA 220848 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENDOMETRIN on 2026-07-16. The source metadata identifies NDA 022057 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TEGRETOL, TEGRETOL-XR on 2026-07-16. The source metadata identifies NDA 016608, NDA 018927, NDA 020234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to San Jorge Produce LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Island Kinetics, Inc. d.b.a. CoValence Laboratories concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for RETEVMO on 2026-07-15. The source metadata identifies NDA 213246, NDA 218160 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SEROSTIM, SEROSTIM LQ on 2026-07-15. The source metadata identifies BLA 020604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REVTORPYK on 2026-07-15. The source metadata identifies NDA 219908 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYOGREEN on 2026-07-13. The source metadata identifies NDA 218579 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-07-13. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TUXARIN ER on 2026-07-13. The source metadata identifies NDA 206323 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-07-13. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SARCLISA ESCENA on 2026-07-13. The source metadata identifies BLA 761445 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XELSTRYM on 2026-07-13. The source metadata identifies NDA 215401 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PADCEV on 2026-07-13. The source metadata identifies BLA 761137 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to BioMylz Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Almon Healthcare Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Shimoga Chemicals concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for LUMVOA on 2026-07-10. The source metadata identifies BLA 761530 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SODIUM BICARBONATE on 2026-07-10. The source metadata identifies NDA 220790 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to indejuicevapestore.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. concerning In Vivo Bioavailability-Bioequivalence Studies – Clinical. Deterministic source-metadata screening identifies discussion of Clinical research and human-subject protections. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to ejuicedemand.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a warning letter to VasoCorp, Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for INBRIJA on 2026-07-08. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRUTAKNA on 2026-07-08. The source metadata identifies BLA 761486 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RYALTRIS on 2026-07-08. The source metadata identifies NDA 211746 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SPORANOX on 2026-07-08. The source metadata identifies NDA 020083, NDA 020657 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Beauty Store LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic source-metadata screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Spa De Soleil, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to IJAJ Group Inc DBA Sanz Wholesale Foods concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for LEVOTHYROXINE SODIUM on 2026-07-07. The source metadata identifies NDA 202231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELOCON on 2026-07-07. The source metadata identifies NDA 019625, NDA 019543, NDA 019796 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RYZUMVI on 2026-07-06. The source metadata identifies NDA 217064 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYRTEC ALLERGY on 2026-07-06. The source metadata identifies NDA 022578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KISQALI on 2026-07-06. The source metadata identifies NDA 209092 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FETROJA on 2026-07-06. The source metadata identifies NDA 209445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RIVAROXABAN on 2026-07-06. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RIVAROXABAN on 2026-07-06. The source metadata identifies ANDA 220874 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KISQALI FEMARA CO-PACK (COPACKAGED) on 2026-07-06. The source metadata identifies NDA 209935 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for TRUXIMA on 2026-07-02. The source metadata identifies BLA 761088 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ONAPGO on 2026-07-02. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QSYMIA on 2026-07-02. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPZELURA on 2026-07-02. The source metadata identifies NDA 215309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STRATTERA on 2026-07-02. The source metadata identifies NDA 021411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ABANTA on 2026-07-02. The source metadata identifies NDA 221024 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MAYZENT on 2026-07-02. The source metadata identifies NDA 209884 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COPAXONE on 2026-07-02. The source metadata identifies NDA 020622 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HEPZATO on 2026-07-02. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOLIRIS on 2026-07-02. The source metadata identifies BLA 125166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ANZUPGO on 2026-07-02. The source metadata identifies NDA 219155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XELJANZ on 2026-07-02. The source metadata identifies NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for COLUMVI on 2026-07-02. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XELJANZ, XELJANZ XR on 2026-07-02. The source metadata identifies NDA 203214, NDA 208246 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOTYKTU on 2026-07-02. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ISTURISA on 2026-07-02. The source metadata identifies NDA 212801 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPYSQLI on 2026-07-02. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CIBINQO on 2026-07-02. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BKEMV on 2026-07-02. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OLUMIANT on 2026-07-02. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LEQSELVI on 2026-07-02. The source metadata identifies NDA 217900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RINVOQ, RINVOQ LQ on 2026-07-02. The source metadata identifies NDA 211675, NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PARLODEL on 2026-07-02. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ERLEADA on 2026-07-02. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZORYVE on 2026-07-02. The source metadata identifies NDA 215985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LITFULO on 2026-07-02. The source metadata identifies NDA 215830 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TASCENSO ODT on 2026-07-02. The source metadata identifies NDA 214962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to International Medication Systems Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to eliquidflavourconcentrates.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to snusblast.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Piquin Y Sabores Distributors LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for ROMVIMZA on 2026-06-30. The source metadata identifies NDA 219304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRELSTAR on 2026-06-30. The source metadata identifies NDA 020715, NDA 021288, NDA 022437 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEVTERA on 2026-06-30. The source metadata identifies NDA 218275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SKYRIZI on 2026-06-30. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SARCLISA on 2026-06-30. The source metadata identifies BLA 761113 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN 0.9% SODIUM CHLORIDE on 2026-06-30. The source metadata identifies NDA 206769 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for CEFEPIME IN PLASTIC CONTAINER on 2026-06-29. The source metadata identifies NDA 050817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BICILLIN L-A, BICILLIN C-R, BICILLIN C-R 900/300 on 2026-06-29. The source metadata identifies NDA 050141, NDA 050138 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for Xeomin on 2026-06-29. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARIKAYCE KIT on 2026-06-29. The source metadata identifies NDA 207356 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BICILLIN C-R, BICILLIN C-R 900/300, BICILLIN L-A on 2026-06-29. The source metadata identifies NDA 050138, NDA 050141 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-06-29. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BESREMI on 2026-06-29. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Balkanica LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for ORSERDU on 2026-06-26. The source metadata identifies NDA 217639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IBRANCE on 2026-06-26. The source metadata identifies NDA 212436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IBRANCE on 2026-06-26. The source metadata identifies NDA 207103 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-26. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRODELVY on 2026-06-26. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SPRAVATO on 2026-06-26. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-06-26. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRODELVY on 2026-06-26. The source metadata identifies BLA 761115 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRYNGOLZA (AUTOINJECTOR) on 2026-06-26. The source metadata identifies NDA 218614 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-26. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ELIQUIS, ELIQUIS SPRINKLE on 2026-06-26. The source metadata identifies NDA 202155, NDA 220073 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NAVITRUX on 2026-06-26. The source metadata identifies NDA 220436 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Excelvision - Fareva concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for PROLIA, XGEVA on 2026-06-24. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROLIA, XGEVA on 2026-06-24. The source metadata identifies BLA 125320 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Wizcure Pharmaa Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Win Woo Trading, LLC / HF Foods Group concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for XTAMPZA ER on 2026-06-23. The source metadata identifies NDA 208090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR) on 2026-06-23. The source metadata identifies NDA 214231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MS CONTIN on 2026-06-23. The source metadata identifies NDA 019516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA on 2026-06-23. The source metadata identifies NDA 203794 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DILAUDID on 2026-06-23. The source metadata identifies NDA 019891, NDA 019892 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 on 2026-06-23. The source metadata identifies NDA 018891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FIORICET W/ CODEINE on 2026-06-23. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ISOVUE-M 200, ISOVUE-300, ISOVUE-370 on 2026-06-23. The source metadata identifies NDA 018735, NDA 020327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200535 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CYSVIEW KIT on 2026-06-23. The source metadata identifies NDA 022555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SYNALGOS-DC on 2026-06-23. The source metadata identifies NDA 011483 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MORPHINE SULFATE on 2026-06-23. The source metadata identifies NDA 022207 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXAYDO on 2026-06-23. The source metadata identifies NDA 202080 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CONZIP on 2026-06-23. The source metadata identifies NDA 022370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QDOLO on 2026-06-23. The source metadata identifies NDA 214044 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PYRUKYND, AQVESME on 2026-06-23. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 200534 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PERCODAN-DEMI, PERCODAN on 2026-06-23. The source metadata identifies NDA 007337 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MORPHINE SULFATE on 2026-06-23. The source metadata identifies NDA 022195 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BELBUCA on 2026-06-23. The source metadata identifies NDA 207932 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA on 2026-06-23. The source metadata identifies NDA 022304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 022402 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEMEROL on 2026-06-23. The source metadata identifies NDA 005010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROXICODONE on 2026-06-23. The source metadata identifies NDA 021011 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCODONE HYDROCHLORIDE on 2026-06-23. The source metadata identifies NDA 201194 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BUTRANS on 2026-06-23. The source metadata identifies NDA 021306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ROXYBOND on 2026-06-23. The source metadata identifies NDA 209777 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NUCYNTA ER on 2026-06-23. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HYSINGLA ER on 2026-06-23. The source metadata identifies NDA 206627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OXYCONTIN on 2026-06-23. The source metadata identifies NDA 022272 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 202245 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TWIRLA on 2026-06-23. The source metadata identifies NDA 204017 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to LyfeUnit / www.lyfeunit.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Med Shop Inc / www.medshopinc.com concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Allandale Dairy concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Keta Med Lab / www.ketamedlab.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Legit Ketamine Suppliers / www.legitketaminesuppliers.com concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Extra Medication / www.extramedication.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ketacyn Pharmaceuticals / www.ketacynpharma.com concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to ketaminetroches.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ketdaxandrugs / www.ketdaxandrugs.org concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ket Plug / ketaminelab.org and buyketaminepowderonline.com concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Buy Keta Online / www.buyketaonline.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to All Ketamine HCL / www.allketaminehcl.com concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ketamine Store / www.ketaminestore.org concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Genzyme Ireland Limited concerning CGMP/Deviations/Biologics License Application (BLA). Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for UTEBZI on 2026-06-18. The source metadata identifies NDA 215960 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPKINLY on 2026-06-18. The source metadata identifies BLA 761324 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PARICALCITOL on 2026-06-18. The source metadata identifies NDA 205917 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BALOXAVIR MARBOXIL on 2026-06-18. The source metadata identifies ANDA 217449 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OCREVUS ZUNOVO on 2026-06-18. The source metadata identifies BLA 761371 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for APREPITANT on 2026-06-17. The source metadata identifies NDA 218754 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN on 2026-06-17. The source metadata identifies NDA 020883 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMODIUM MULTI-SYMPTOM RELIEF on 2026-06-17. The source metadata identifies NDA 021140 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Texinkart Inc. concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Herbal Dermals LLC FZ dba Gotucream concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Hadassah Healing Oils Ltd concerning Unapproved New Drugs. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Telos Trading Limited dba Alwinshop concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Leading Edge Health Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Wild Arabic Herbs concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Indiangoods.shop concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Great India Overseas Pvt. Ltd. dba Silkrute concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Wholesale Peptide concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to MantroForce concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to JJLBRO concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for AMBELVIST on 2026-06-16. The source metadata identifies NDA 219627 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ABSORICA LD on 2026-06-16. The source metadata identifies NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA QLEX on 2026-06-16. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for YERVOY on 2026-06-16. The source metadata identifies BLA 125377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TRUQAP on 2026-06-16. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, SKYRIZI on 2026-06-16. The source metadata identifies ANDA 076126, BLA 761105 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for REXTOVY on 2026-06-16. The source metadata identifies NDA 208969 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WIDAPLIK on 2026-06-16. The source metadata identifies NDA 219423 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WELIREG on 2026-06-16. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Diamond Distributions LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for ALECENSA on 2026-06-15. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 10% IN PLASTIC CONTAINER on 2026-06-15. The source metadata identifies NDA 016673, NDA 016694 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BAXFENDY on 2026-06-15. The source metadata identifies NDA 219878 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TZIELD on 2026-06-15. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Life & Food Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Happiest Baby, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic source-metadata screening identifies discussion of Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Huons Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Yangzhou Hongshengding Chemical Co., Ltd. concerning Refusal to Provide Access to and Copying of Records. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to AHC Products, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nihon Kohden Digital Health Solutions, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-06-11. The source metadata identifies NDA 206473 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EXDENSUR on 2026-06-11. The source metadata identifies BLA 761458 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-06-11. The source metadata identifies NDA 022434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER on 2026-06-11. The source metadata identifies NDA 050671 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VORANIGO on 2026-06-11. The source metadata identifies NDA 218784 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FLUORESCITE on 2026-06-11. The source metadata identifies NDA 021980 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DARZALEX on 2026-06-11. The source metadata identifies BLA 761036 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TERLIVAZ on 2026-06-11. The source metadata identifies NDA 022231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOTYKTU on 2026-06-11. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZYVOX on 2026-06-11. The source metadata identifies NDA 021130, NDA 021131, NDA 021132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EBGLYSS on 2026-06-11. The source metadata identifies BLA 761306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-06-11. The source metadata identifies NDA 209552 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-06-11. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CEPHALEXIN on 2026-06-11. The source metadata identifies ANDA 213568 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued an approval letter for RIFAXIMIN on 2026-06-09. The source metadata identifies ANDA 208959 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211583 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MESALAMINE on 2026-06-09. The source metadata identifies ANDA 219997 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for PROVOCHOLINE on 2026-06-09. The source metadata identifies NDA 019193 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE) on 2026-06-09. The source metadata identifies ANDA 210456 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION PEDIATRIC on 2026-06-09. The source metadata identifies ANDA 210671 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CANAGLIFLOZIN on 2026-06-09. The source metadata identifies ANDA 210449 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-06-09. The source metadata identifies ANDA 210273 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OPDUALAG on 2026-06-09. The source metadata identifies BLA 761234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for HYMPAVZI on 2026-06-09. The source metadata identifies BLA 761369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EPIDIOLEX on 2026-06-09. The source metadata identifies NDA 210365 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for EMGALITY on 2026-06-09. The source metadata identifies BLA 761063 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 218760 on 2026-06-09. The source metadata identifies ANDA 218760 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211563 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NINTEDANIB ESYLATE on 2026-06-09. The source metadata identifies ANDA 212609 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for APREPITANT on 2026-06-09. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ALBUTEROL SULFATE on 2026-06-09. The source metadata identifies ANDA 219409 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ENZALUTAMIDE on 2026-06-09. The source metadata identifies ANDA 216068 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CITALOPRAM HYDROBROMIDE on 2026-06-09. The source metadata identifies ANDA 219985 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 212211 on 2026-06-09. The source metadata identifies ANDA 212211 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IMULDOSA on 2026-06-09. The source metadata identifies BLA 761364 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for VYEPTI on 2026-06-09. The source metadata identifies BLA 761119 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FERRIC CITRATE on 2026-06-09. The source metadata identifies ANDA 212563 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for DAPAGLIFLOZIN on 2026-06-09. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220169 on 2026-06-08. The source metadata identifies ANDA 220169 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220025 on 2026-06-08. The source metadata identifies ANDA 220025 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for TOFACITINIB CITRATE on 2026-06-08. The source metadata identifies ANDA 215356 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE on 2026-06-08. The source metadata identifies ANDA 220483 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CHILDREN'S ALLEGRA ALLERGY, CHILDREN'S ALLEGRA HIVES on 2026-06-08. The source metadata identifies NDA 021909 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VILOXAZINE HYDROCHLORIDE on 2026-06-08. The source metadata identifies ANDA 220326 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220264 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for VERICIGUAT on 2026-06-08. The source metadata identifies ANDA 220221 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 220352 on 2026-06-08. The source metadata identifies ANDA 220352 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Maximus Health, Inc. dba Maximus concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Medica Weight Loss concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to HydraMed IV LLC dba HydraMed concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to FITISH concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Momentum Health 360 dba Momentum Health concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ezra Holdco LLC dba Ezra concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nova Vascular LLC dba NOVARX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to NativeMed LLC dba NativeMed concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Delight Distribution Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to OrderlyMeds LLC dba OrderlyMeds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Eden Health International Inc. dba Eden concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to D&H Medical Services concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Roen Health, Inc. dba RoenRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Trinity HealthCare Supply, LLC dba altRx concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Vivot LLC concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Altru Telehealth, LLC dba Altru Telehealth concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nexlife Inc. dba Nexlife concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Public Health Solution LLC dba DrMedHealth concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to VivioMD Group LLC dba VivioMD concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Ready Med concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Joi and Blokes dba Joi + Blokes concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Amie Health, Inc. dba Amie concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nexus Health Solutions LLC dba Harper Meds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Clover Meds LLC dba Clover Meds concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to FitRX, LLC dba AM RX concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to YS Group Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Thrivelab Co. dba Thrivelab concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Glow Medispa, LLC dba Mint Med concerning False & Misleading Claims/Misbranded (Telehealth). Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a tentative approval letter for CENOBAMATE on 2026-06-05. The source metadata identifies ANDA 219473 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STEGLUJAN on 2026-06-05. The source metadata identifies NDA 209805 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for CYCLOPHOSPHAMIDE on 2026-06-05. The source metadata identifies ANDA 219271 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FASENRA on 2026-06-05. The source metadata identifies BLA 761070 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for STEGLATRO on 2026-06-05. The source metadata identifies NDA 209803 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for FARXIGA on 2026-06-05. The source metadata identifies NDA 202293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for QTERN on 2026-06-05. The source metadata identifies NDA 209091 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ARGATROBAN IN DEXTROSE on 2026-06-05. The source metadata identifies NDA 201743 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for INVOKANA on 2026-06-05. The source metadata identifies NDA 204042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRENZAVVY on 2026-06-05. The source metadata identifies NDA 214373 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to Imu-Tek Animal Health, Incorporated concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Mineral BioSciences, LLC concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Sante Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.

FDA issued a warning letter to AseptiKits, LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Nutratech, LLC concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for FUROSEMIDE on 2026-06-03. The source metadata identifies NDA 018569 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SAXENDA on 2026-06-03. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for RANLUSPEC on 2026-06-03. The source metadata identifies BLA 761480 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a warning letter to BlephEx, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.

FDA issued a warning letter to InvaDerm, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.

FDA issued an approval letter for ARFORMOTEROL TARTRATE on 2026-06-02. The source metadata identifies ANDA 218429 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for ZAYNICH on 2026-06-02. The source metadata identifies NDA 220787 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for BRIVARACETAM on 2026-06-02. The source metadata identifies ANDA 214924 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for CAVHANZA on 2026-06-02. The source metadata identifies NDA 217379 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for XOCOVA on 2026-06-02. The source metadata identifies NDA 220442 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for OZEMPIC on 2026-06-02. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for WELLCOVORIN on 2026-06-02. The source metadata identifies NDA 018342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for IDELALISIB on 2026-06-02. The source metadata identifies ANDA 216921 as an original application. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for AJOVY on 2026-06-02. The source metadata identifies BLA 761089 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for KEYTRUDA on 2026-06-02. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued an approval letter for SOLIRIS, ULTOMIRIS on 2026-06-02. The source metadata identifies BLA 125166, BLA 761108 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

FDA issued a tentative approval letter for ANDA 217060 on 2026-06-02. The source metadata identifies ANDA 217060 as an original application. Review the exact FDA letter for the approved conditions and labeling.