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 1381-1392 of 1503 letters

ALApproval Letter
Approval Letter BAYER HLTHCARE (Feb 5, 2026)
FDA issued an approval letter for STIVARGA on 2026-02-05. The source metadata identifies NDA 203085 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 5, 2026
US FDA• STIVARGA
ALApproval Letter
Approval Letter APIL (Feb 5, 2026)
FDA issued an approval letter for ACTONEL on 2026-02-05. The source metadata identifies NDA 020835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 5, 2026
US FDA• ACTONEL
ALApproval Letter
Approval Letter APIL (Feb 5, 2026)
FDA issued an approval letter for ATELVIA on 2026-02-05. The source metadata identifies NDA 022560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 5, 2026
US FDA• ATELVIA
ALApproval Letter
Approval Letter SANDOZ (Feb 5, 2026)
FDA issued an approval letter for RECLAST on 2026-02-05. The source metadata identifies NDA 021817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 5, 2026
US FDA• RECLAST
ALApproval Letter
Approval Letter XTTRIUM (Feb 5, 2026)
FDA issued an approval letter for DYNA-HEX 4 on 2026-02-05. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 5, 2026
US FDA• DYNA-HEX 4
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Feb 5, 2026)
FDA issued an approval letter for ATROPINE SULFATE on 2026-02-05. The source metadata identifies NDA 214652 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 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 source-metadata screening identifies discussion of Manufacturing and CGMP controls. 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
WLWarning Letter
Warning Letter Beach Weekend Management LLC dba Nic and Jet Fuel (Feb 5, 2026)
FDA issued a warning letter to Beach Weekend Management LLC dba Nic and Jet Fuel concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Labeling, claims, and misbranding, 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.
IssuedFeb 5, 2026
US FDA• Unapproved New Drugs
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Feb 3, 2026)
FDA issued an approval letter for LIVDELZI on 2026-02-03. The source metadata identifies NDA 217899 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 3, 2026
US FDA• LIVDELZI
ALApproval Letter
Approval Letter APOTEX (Feb 3, 2026)
FDA issued an approval letter for EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE on 2026-02-03. The source metadata identifies ANDA 214095 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 3, 2026
US FDA• EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
ALApproval Letter
Approval Letter ALKERMES INC (Feb 3, 2026)
FDA issued an approval letter for LYBALVI on 2026-02-03. The source metadata identifies NDA 213378 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 3, 2026
US FDA• LYBALVI
ALApproval Letter
Approval Letter CHEPLAPHARM (Feb 3, 2026)
FDA issued an approval letter for ZYPREXA, ZYPREXA ZYDIS, ZYPREXA RELPREVV on 2026-02-03. The source metadata identifies NDA 020592, NDA 021086, NDA 021253, NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 3, 2026
US FDA• ZYPREXA / ZYPREXA ZYDIS / ZYPREXA RELPREVV

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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)

Warning Letter Beach Weekend Management LLC dba Nic and Jet Fuel (Feb 5, 2026)

Approval Letter GILEAD SCIENCES INC (Feb 3, 2026)

Approval Letter APOTEX (Feb 3, 2026)

Approval Letter ALKERMES INC (Feb 3, 2026)

Approval Letter CHEPLAPHARM (Feb 3, 2026)