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 1,819 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 601-612 of 1819 letters

ALApproval Letter
Approval Letter DELCATH SYSTEMS INC (Aug 13, 2026)
FDA posted an approval letter for HEPZATO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 13, 2026
US FDA• HEPZATO
ALApproval Letter
Approval Letter OXFORD PHARMS (Aug 13, 2026)
FDA posted an approval letter for RIMACTANE on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050429 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 13, 2026
US FDA• RIMACTANE
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Aug 13, 2026)
FDA posted an approval letter for OPDIVO on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 13, 2026
US FDA• OPDIVO
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Aug 13, 2026)
FDA posted an approval letter for WINREVAIR on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 13, 2026
US FDA• WINREVAIR
WLWarning Letter
Warning Letter Suretec Innovations, LLC (Aug 13, 2026)
FDA issued a warning letter to Suretec Innovations, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated and Misbranded. 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.
IssuedAug 13, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated and Misbranded
WLWarning Letter
Warning Letter Eugia Pharma Specialities Limited (Aug 13, 2026)
FDA issued a warning letter to Eugia Pharma Specialities Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedAug 13, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Bo Wah Enterprises Inc (Aug 13, 2026)
FDA issued a warning letter to Bo Wah Enterprises 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.
IssuedAug 13, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Auriga Research Pvt. Ltd. (Aug 12, 2026)
FDA issued a warning letter to Auriga Research Pvt. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 12, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter K.C. Pharmaceuticals, Inc. (Aug 12, 2026)
FDA issued a warning letter to K.C. Pharmaceuticals, Inc. 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.
IssuedAug 12, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter GENUS (Aug 11, 2026)
FDA posted an approval letter for POTASSIUM CHLORIDE, POKONZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208019 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 11, 2026
US FDA• POTASSIUM CHLORIDE / POKONZA
ALApproval Letter
Approval Letter AGIOS PHARMS INC (Aug 11, 2026)
FDA posted an approval letter for PYRUKYND, AQVESME on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 11, 2026
US FDA• PYRUKYND / AQVESME
ALApproval Letter
Approval Letter GENENTECH INC (Aug 11, 2026)
FDA posted an approval letter for XOFLUZA on 2026-08-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210854 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 11, 2026
US FDA• XOFLUZA

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Approval Letter DELCATH SYSTEMS INC (Aug 13, 2026)

Approval Letter OXFORD PHARMS (Aug 13, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Aug 13, 2026)

Approval Letter MERCK SHARP DOHME (Aug 13, 2026)

Warning Letter Suretec Innovations, LLC (Aug 13, 2026)

Warning Letter Eugia Pharma Specialities Limited (Aug 13, 2026)

Warning Letter Bo Wah Enterprises Inc (Aug 13, 2026)

Warning Letter Auriga Research Pvt. Ltd. (Aug 12, 2026)

Warning Letter K.C. Pharmaceuticals, Inc. (Aug 12, 2026)

Approval Letter GENUS (Aug 11, 2026)

Approval Letter AGIOS PHARMS INC (Aug 11, 2026)

Approval Letter GENENTECH INC (Aug 11, 2026)