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 1441-1452 of 1819 letters

ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Mar 20, 2026)
FDA posted an approval letter for OJJAARA on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• OJJAARA
ALApproval Letter
Approval Letter ABBVIE INC (Mar 20, 2026)
FDA posted an approval letter for SKYRIZI on 2026-03-20. 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 20, 2026
US FDA• SKYRIZI
ALApproval Letter
Approval Letter BRISTOL-MYERS (Mar 20, 2026)
FDA posted an approval letter for INREBIC on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• INREBIC
ALApproval Letter
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)
FDA posted an approval letter for XTORO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• XTORO
ALApproval Letter
Approval Letter HARROW EYE (Mar 20, 2026)
FDA posted an approval letter for IOPIDINE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019779 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• IOPIDINE
ALApproval Letter
Approval Letter PROVEPHARM SAS (Mar 20, 2026)
FDA posted an approval letter for BAL on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• BAL
ALApproval Letter
Approval Letter LUNDBECK PHARMS LLC (Mar 20, 2026)
FDA posted an approval letter for SABRIL on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020427, NDA 022006 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• SABRIL
TATentative Approval Letter
Tentative Approval Letter APPCO PHARMA LLC (Mar 20, 2026)
FDA posted a tentative approval letter for ANDA 220327 on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220327 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• ANDA 220327
ALApproval Letter
Approval Letter HARROW EYE (Mar 20, 2026)
FDA posted an approval letter for IOPIDINE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020258 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• IOPIDINE
TATentative Approval Letter
Tentative Approval Letter APOTEX INC (Mar 20, 2026)
FDA posted a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ALApproval Letter
Approval Letter SOBI (Mar 20, 2026)
FDA posted an approval letter for VONJO on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• VONJO
ALApproval Letter
Approval Letter GENENTECH (Mar 20, 2026)
FDA posted an approval letter for POLIVY on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• POLIVY

Page 121 of 152

1…119 120 121 122 123…152

Approval Letter GLAXOSMITHKLINE (Mar 20, 2026)

Approval Letter ABBVIE INC (Mar 20, 2026)

Approval Letter BRISTOL-MYERS (Mar 20, 2026)

Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)

Approval Letter HARROW EYE (Mar 20, 2026)

Approval Letter PROVEPHARM SAS (Mar 20, 2026)

Approval Letter LUNDBECK PHARMS LLC (Mar 20, 2026)

Tentative Approval Letter APPCO PHARMA LLC (Mar 20, 2026)

Approval Letter HARROW EYE (Mar 20, 2026)

Tentative Approval Letter APOTEX INC (Mar 20, 2026)

Approval Letter SOBI (Mar 20, 2026)

Approval Letter GENENTECH (Mar 20, 2026)