FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,503 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 457-468 of 1503 letters

ALApproval Letter
Approval Letter MAINPOINTE (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• TUXARIN ER
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• KEYTRUDA QLEX
ALApproval Letter
Approval Letter SANOFI-AVENTIS U.S. LLC (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• SARCLISA ESCENA
ALApproval Letter
Approval Letter NOVEN PHARMS INC (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• XELSTRYM
ALApproval Letter
Approval Letter ASTELLAS (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• PADCEV
WLWarning Letter
Warning Letter BioMylz Pvt. Ltd. (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
WLWarning Letter
Warning Letter Almon Healthcare Private Limited (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
WLWarning Letter
Warning Letter Shimoga Chemicals (Jul 13, 2026)
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.
IssuedJul 13, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
ALApproval Letter
Approval Letter VIRIDIAN THERAPEUTICS INC (Jul 10, 2026)
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.
IssuedJul 10, 2026
US FDA• LUMVOA
ALApproval Letter
Approval Letter AMNEAL (Jul 10, 2026)
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.
IssuedJul 10, 2026
US FDA• SODIUM BICARBONATE
WLWarning Letter
Warning Letter indejuicevapestore.co.uk (Jul 10, 2026)
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.
IssuedJul 10, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. (Jul 10, 2026)
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.
IssuedJul 10, 2026
US FDA• In Vivo Bioavailability-Bioequivalence Studies – Clinical

Page 39 of 126

1…37 38 39 40 41…126

Approval Letter MAINPOINTE (Jul 13, 2026)

Approval Letter MERCK SHARP DOHME (Jul 13, 2026)

Approval Letter SANOFI-AVENTIS U.S. LLC (Jul 13, 2026)

Approval Letter NOVEN PHARMS INC (Jul 13, 2026)

Approval Letter ASTELLAS (Jul 13, 2026)

Warning Letter BioMylz Pvt. Ltd. (Jul 13, 2026)

Warning Letter Almon Healthcare Private Limited (Jul 13, 2026)

Warning Letter Shimoga Chemicals (Jul 13, 2026)

Approval Letter VIRIDIAN THERAPEUTICS INC (Jul 10, 2026)

Approval Letter AMNEAL (Jul 10, 2026)

Warning Letter indejuicevapestore.co.uk (Jul 10, 2026)

Warning Letter Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. (Jul 10, 2026)