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 805-816 of 1819 letters

ALApproval Letter
Approval Letter LILLY (Jul 2, 2026)
FDA posted an approval letter for STRATTERA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• STRATTERA
TATentative Approval Letter
Tentative Approval Letter AZURITY (Jul 2, 2026)
FDA posted a tentative approval letter for ABANTA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221024 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ABANTA
ALApproval Letter
Approval Letter NOVARTIS (Jul 2, 2026)
FDA posted an approval letter for MAYZENT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209884 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• MAYZENT
ALApproval Letter
Approval Letter TEVA PHARMS USA (Jul 2, 2026)
FDA posted an approval letter for COPAXONE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020622 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• COPAXONE
ALApproval Letter
Approval Letter DELCATH SYSTEMS INC (Jul 2, 2026)
FDA posted an approval letter for HEPZATO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201848 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• HEPZATO
ALApproval Letter
Approval Letter ALEXION PHARM (Jul 2, 2026)
FDA posted an approval letter for SOLIRIS on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• SOLIRIS
ALApproval Letter
Approval Letter LEO PHARMA AS (Jul 2, 2026)
FDA posted an approval letter for ANZUPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ANZUPGO
ALApproval Letter
Approval Letter PFIZER (Jul 2, 2026)
FDA posted an approval letter for XELJANZ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• XELJANZ
ALApproval Letter
Approval Letter GENENTECH INC (Jul 2, 2026)
FDA posted an approval letter for COLUMVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• COLUMVI
ALApproval Letter
Approval Letter PF PRISM CV (Jul 2, 2026)
FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• XELJANZ / XELJANZ XR
ALApproval Letter
Approval Letter BRISTOL (Jul 2, 2026)
FDA posted an approval letter for SOTYKTU on 2026-07-02. 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 FDAJul 2, 2026
US FDA• SOTYKTU
ALApproval Letter
Approval Letter RECORDATI RARE (Jul 2, 2026)
FDA posted an approval letter for ISTURISA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212801 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ISTURISA

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Approval Letter LILLY (Jul 2, 2026)

Tentative Approval Letter AZURITY (Jul 2, 2026)

Approval Letter NOVARTIS (Jul 2, 2026)

Approval Letter TEVA PHARMS USA (Jul 2, 2026)

Approval Letter DELCATH SYSTEMS INC (Jul 2, 2026)

Approval Letter ALEXION PHARM (Jul 2, 2026)

Approval Letter LEO PHARMA AS (Jul 2, 2026)

Approval Letter PFIZER (Jul 2, 2026)

Approval Letter GENENTECH INC (Jul 2, 2026)

Approval Letter PF PRISM CV (Jul 2, 2026)

Approval Letter BRISTOL (Jul 2, 2026)

Approval Letter RECORDATI RARE (Jul 2, 2026)