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 1693-1704 of 1819 letters

ALApproval Letter
Approval Letter XTTRIUM (Feb 5, 2026)
FDA posted an approval letter for DYNA-HEX 2 on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• DYNA-HEX 2
ALApproval Letter
Approval Letter RADIUS (Feb 5, 2026)
FDA posted an approval letter for BINOSTO on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202344 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• BINOSTO
ALApproval Letter
Approval Letter ORGANON (Feb 5, 2026)
FDA posted an approval letter for FOSAMAX on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• FOSAMAX
ALApproval Letter
Approval Letter ORGANON LLC (Feb 5, 2026)
FDA posted an approval letter for FOSAMAX PLUS D on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021762 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• FOSAMAX PLUS D
ALApproval Letter
Approval Letter AVYXA HOLDINGS (Feb 5, 2026)
FDA posted an approval letter for VYKOURA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220406 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• VYKOURA
ALApproval Letter
Approval Letter BAYER HLTHCARE (Feb 5, 2026)
FDA posted an approval letter for STIVARGA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• STIVARGA
ALApproval Letter
Approval Letter APIL (Feb 5, 2026)
FDA posted an approval letter for ACTONEL on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• ACTONEL
ALApproval Letter
Approval Letter APIL (Feb 5, 2026)
FDA posted an approval letter for ATELVIA on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• ATELVIA
ALApproval Letter
Approval Letter SANDOZ (Feb 5, 2026)
FDA posted an approval letter for RECLAST on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• RECLAST
ALApproval Letter
Approval Letter XTTRIUM (Feb 5, 2026)
FDA posted an approval letter for DYNA-HEX 4 on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• DYNA-HEX 4
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Feb 5, 2026)
FDA posted an approval letter for ATROPINE SULFATE on 2026-02-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214652 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 5, 2026
US FDA• ATROPINE SULFATE
WLWarning Letter
Warning Letter Bio-Medical Pharmaceutical Manufacturing Corporation (Feb 5, 2026)
FDA issued a warning letter to Bio-Medical Pharmaceutical Manufacturing Corporation 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.
IssuedFeb 5, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

Page 142 of 152

1…140 141 142 143 144…152

Approval Letter XTTRIUM (Feb 5, 2026)

Approval Letter RADIUS (Feb 5, 2026)

Approval Letter ORGANON (Feb 5, 2026)

Approval Letter ORGANON LLC (Feb 5, 2026)

Approval Letter AVYXA HOLDINGS (Feb 5, 2026)

Approval Letter BAYER HLTHCARE (Feb 5, 2026)

Approval Letter APIL (Feb 5, 2026)

Approval Letter APIL (Feb 5, 2026)

Approval Letter SANDOZ (Feb 5, 2026)

Approval Letter XTTRIUM (Feb 5, 2026)

Approval Letter ACCORD HLTHCARE (Feb 5, 2026)

Warning Letter Bio-Medical Pharmaceutical Manufacturing Corporation (Feb 5, 2026)