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 1357-1368 of 1819 letters

ALApproval Letter
Approval Letter AKEBIA (Apr 2, 2026)
FDA posted an approval letter for VAFSEO on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215192 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 2, 2026
US FDA• VAFSEO
ALApproval Letter
Approval Letter ABBVIE (Apr 2, 2026)
FDA posted an approval letter for DEPAKOTE, DEPAKOTE ER on 2026-04-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018723, NDA 019680, NDA 021168 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 2, 2026
US FDA• DEPAKOTE / DEPAKOTE ER
WLWarning Letter
Warning Letter Purolea Cosmetics Lab (Apr 2, 2026)
FDA issued a warning letter to Purolea Cosmetics Lab concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, 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.
IssuedApr 2, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
WLWarning Letter
Warning Letter Beauty of Aztlan LLC (Apr 2, 2026)
FDA issued a warning letter to Beauty of Aztlan LLC concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. 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.
IssuedApr 2, 2026
US FDA• Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
ALApproval Letter
Approval Letter PYROS PHARMS (Apr 1, 2026)
FDA posted an approval letter for VIGAFYDE on 2026-04-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217684 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 1, 2026
US FDA• VIGAFYDE
WLWarning Letter
Warning Letter Rxgoodusa (Apr 1, 2026)
FDA issued a warning letter to Rxgoodusa concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. 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.
IssuedApr 1, 2026
US FDA• Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
WLWarning Letter
Warning Letter Online Rx Medz (Apr 1, 2026)
FDA issued a warning letter to Online Rx Medz concerning Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet. 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.
IssuedApr 1, 2026
US FDA• Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
WLWarning Letter
Warning Letter Dry Springs Pharmacy (Apr 1, 2026)
FDA issued a warning letter to Dry Springs Pharmacy concerning Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet. 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.
IssuedApr 1, 2026
US FDA• Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
WLWarning Letter
Warning Letter Pure Indulgence Aesthetics (Apr 1, 2026)
FDA issued a warning letter to Pure Indulgence Aesthetics concerning Drug Supply Chain Security Act (DSCSA) Violations. 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.
IssuedApr 1, 2026
US FDA• Drug Supply Chain Security Act (DSCSA) Violations
ALApproval Letter
Approval Letter IBSA INST BIO (Mar 31, 2026)
FDA posted an approval letter for LICART on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206976 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• LICART
ALApproval Letter
Approval Letter GENMAB US, INC. (Mar 31, 2026)
FDA posted an approval letter for EPKINLY on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761324 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• EPKINLY
ALApproval Letter
Approval Letter CHIESI (Mar 31, 2026)
FDA posted an approval letter for CARDENE, CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• CARDENE / CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER / CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

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Approval Letter AKEBIA (Apr 2, 2026)

Approval Letter ABBVIE (Apr 2, 2026)

Warning Letter Purolea Cosmetics Lab (Apr 2, 2026)

Warning Letter Beauty of Aztlan LLC (Apr 2, 2026)

Approval Letter PYROS PHARMS (Apr 1, 2026)

Warning Letter Rxgoodusa (Apr 1, 2026)

Warning Letter Online Rx Medz (Apr 1, 2026)

Warning Letter Dry Springs Pharmacy (Apr 1, 2026)

Warning Letter Pure Indulgence Aesthetics (Apr 1, 2026)

Approval Letter IBSA INST BIO (Mar 31, 2026)

Approval Letter GENMAB US, INC. (Mar 31, 2026)

Approval Letter CHIESI (Mar 31, 2026)