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 1501-1512 of 1819 letters

ALApproval Letter
Approval Letter NEXTWAVE (Mar 10, 2026)
FDA posted an approval letter for QUILLIVANT XR on 2026-03-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202100 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 10, 2026
US FDA• QUILLIVANT XR
ALApproval Letter
Approval Letter SUPERNUS PHARMS (Mar 9, 2026)
FDA posted an approval letter for TROKENDI XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201635 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• TROKENDI XR
ALApproval Letter
Approval Letter JANSSEN PHARMS (Mar 9, 2026)
FDA posted an approval letter for TOPAMAX, TOPAMAX SPRINKLE on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020505, NDA 020844 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• TOPAMAX / TOPAMAX SPRINKLE
ALApproval Letter
Approval Letter PF PRISM CV (Mar 9, 2026)
FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• XELJANZ / XELJANZ XR
ALApproval Letter
Approval Letter PRAGMA (Mar 9, 2026)
FDA posted an approval letter for KEFLEX on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050406 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• KEFLEX
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA posted an approval letter for TALVEY on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• TALVEY
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA posted an approval letter for TECVAYLI on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761291 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• TECVAYLI
ALApproval Letter
Approval Letter CHATTEM SANOFI (Mar 9, 2026)
FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• XYZAL ALLERGY 24HR
ALApproval Letter
Approval Letter BRISTOL (Mar 9, 2026)
FDA posted an approval letter for SOTYKTU on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• SOTYKTU
ALApproval Letter
Approval Letter VIVUS LLC (Mar 9, 2026)
FDA posted an approval letter for QSYMIA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• QSYMIA
ALApproval Letter
Approval Letter ABBVIE INC (Mar 9, 2026)
FDA posted an approval letter for SKYRIZI on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761105, BLA 761262 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• SKYRIZI
ALApproval Letter
Approval Letter AZURITY (Mar 9, 2026)
FDA posted an approval letter for EPRONTIA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214679 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• EPRONTIA

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Approval Letter NEXTWAVE (Mar 10, 2026)

Approval Letter SUPERNUS PHARMS (Mar 9, 2026)

Approval Letter JANSSEN PHARMS (Mar 9, 2026)

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)