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 1189-1200 of 1503 letters

ALApproval Letter
Approval Letter PF PRISM CV (Mar 9, 2026)
FDA issued an approval letter for XELJANZ, XELJANZ XR on 2026-03-09. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• XELJANZ / XELJANZ XR
ALApproval Letter
Approval Letter PRAGMA (Mar 9, 2026)
FDA issued an approval letter for KEFLEX on 2026-03-09. The source metadata identifies NDA 050406 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• KEFLEX
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA issued an approval letter for TALVEY on 2026-03-09. The source metadata identifies BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• TALVEY
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA issued an approval letter for TECVAYLI on 2026-03-09. The source metadata identifies BLA 761291 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• TECVAYLI
ALApproval Letter
Approval Letter CHATTEM SANOFI (Mar 9, 2026)
FDA issued an approval letter for XYZAL ALLERGY 24HR on 2026-03-09. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• XYZAL ALLERGY 24HR
ALApproval Letter
Approval Letter BRISTOL (Mar 9, 2026)
FDA issued an approval letter for SOTYKTU on 2026-03-09. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• SOTYKTU
ALApproval Letter
Approval Letter VIVUS LLC (Mar 9, 2026)
FDA issued an approval letter for QSYMIA on 2026-03-09. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• QSYMIA
ALApproval Letter
Approval Letter ABBVIE INC (Mar 9, 2026)
FDA issued an approval letter for SKYRIZI on 2026-03-09. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• SKYRIZI
ALApproval Letter
Approval Letter AZURITY (Mar 9, 2026)
FDA issued an approval letter for EPRONTIA on 2026-03-09. The source metadata identifies NDA 214679 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• EPRONTIA
ALApproval Letter
Approval Letter NOVARTIS (Mar 9, 2026)
FDA issued an approval letter for SANDIMMUNE on 2026-03-09. The source metadata identifies NDA 050573, NDA 050574, NDA 050625 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• SANDIMMUNE
ALApproval Letter
Approval Letter UPSHER SMITH LABS (Mar 9, 2026)
FDA issued an approval letter for QUDEXY XR on 2026-03-09. The source metadata identifies NDA 205122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• QUDEXY XR
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA issued an approval letter for ERLEADA on 2026-03-09. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• ERLEADA

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Approval Letter PF PRISM CV (Mar 9, 2026)

Approval Letter PRAGMA (Mar 9, 2026)

Approval Letter JANSSEN BIOTECH (Mar 9, 2026)

Approval Letter JANSSEN BIOTECH (Mar 9, 2026)

Approval Letter CHATTEM SANOFI (Mar 9, 2026)

Approval Letter BRISTOL (Mar 9, 2026)

Approval Letter VIVUS LLC (Mar 9, 2026)

Approval Letter ABBVIE INC (Mar 9, 2026)

Approval Letter AZURITY (Mar 9, 2026)

Approval Letter NOVARTIS (Mar 9, 2026)

Approval Letter UPSHER SMITH LABS (Mar 9, 2026)

Approval Letter JANSSEN BIOTECH (Mar 9, 2026)