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 1645-1656 of 1819 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Feb 13, 2026)
FDA posted an approval letter for PEPCID AC on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020325 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 13, 2026
US FDA• PEPCID AC
ALApproval Letter
Approval Letter ACCORD (Feb 13, 2026)
FDA posted an approval letter for CAMCEVI KIT on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211488 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 13, 2026
US FDA• CAMCEVI KIT
ALApproval Letter
Approval Letter NOVARTIS (Feb 13, 2026)
FDA posted an approval letter for LEQVIO on 2026-02-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214012 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 13, 2026
US FDA• LEQVIO
WLWarning Letter
Warning Letter The Sabagh Group Inc/lighterusa.com (Feb 13, 2026)
FDA issued a warning letter to The Sabagh Group Inc/lighterusa.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, 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.
IssuedFeb 13, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter swedishproducts.online (Feb 13, 2026)
FDA issued a warning letter to swedishproducts.online concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, 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.
IssuedFeb 13, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter MAYNE PHARMA (Feb 12, 2026)
FDA posted an approval letter for BIJUVA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• BIJUVA
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Feb 12, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Feb 12, 2026)
FDA posted an approval letter for KEYTRUDA QLEX on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• KEYTRUDA QLEX
ALApproval Letter
Approval Letter VERTICAL PHARMS (Feb 12, 2026)
FDA posted an approval letter for DIVIGEL on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022038 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• DIVIGEL
ALApproval Letter
Approval Letter SANOFI AVENTIS US (Feb 12, 2026)
FDA posted an approval letter for AUBAGIO on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202992 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• AUBAGIO
ALApproval Letter
Approval Letter ASPEN (Feb 12, 2026)
FDA posted an approval letter for CENESTIN on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020992 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• CENESTIN
ALApproval Letter
Approval Letter ACERTIS PHARMS (Feb 12, 2026)
FDA posted an approval letter for PROMETRIUM on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019781 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• PROMETRIUM

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Approval Letter KENVUE BRANDS (Feb 13, 2026)

Approval Letter ACCORD (Feb 13, 2026)

Approval Letter NOVARTIS (Feb 13, 2026)

Warning Letter The Sabagh Group Inc/lighterusa.com (Feb 13, 2026)

Warning Letter swedishproducts.online (Feb 13, 2026)

Approval Letter MAYNE PHARMA (Feb 12, 2026)

Approval Letter MERCK SHARP DOHME (Feb 12, 2026)

Approval Letter MERCK SHARP DOHME (Feb 12, 2026)

Approval Letter VERTICAL PHARMS (Feb 12, 2026)

Approval Letter SANOFI AVENTIS US (Feb 12, 2026)

Approval Letter ASPEN (Feb 12, 2026)

Approval Letter ACERTIS PHARMS (Feb 12, 2026)