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 397-408 of 1819 letters

ALApproval Letter
Approval Letter ABBVIE INC (Sep 29, 2026)
FDA posted an approval letter for JUVMO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220415 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• JUVMO
ALApproval Letter
Approval Letter AMGEN INC (Sep 29, 2026)
FDA posted an approval letter for RIABNI on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761140 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• RIABNI
ALApproval Letter
Approval Letter INCYTE CORP (Sep 29, 2026)
FDA posted an approval letter for ATEBRIOZ on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221198 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• ATEBRIOZ
ALApproval Letter
Approval Letter ADVENTAPHARMA DWC LLC (Sep 29, 2026)
FDA posted an approval letter for ZUEINO on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218379 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• ZUEINO
ALApproval Letter
Approval Letter PLANO PHARMS (Sep 29, 2026)
FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022485 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• ARGATROBAN IN SODIUM CHLORIDE
ALApproval Letter
Approval Letter GENENTECH (Sep 29, 2026)
FDA posted an approval letter for GAZYVA on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125486 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• GAZYVA
TATentative Approval Letter
Tentative Approval Letter LUPIN (Sep 29, 2026)
FDA posted a tentative approval letter for APIXABAN on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220446 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• APIXABAN
ALApproval Letter
Approval Letter KENVUE BRANDS (Sep 29, 2026)
FDA posted an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-09-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 29, 2026
US FDA• CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Sep 28, 2026)
FDA posted an approval letter for WELIREG on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• WELIREG
ALApproval Letter
Approval Letter WAYLIS THERAP (Sep 28, 2026)
FDA posted an approval letter for VALIUM on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 013263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• VALIUM
ALApproval Letter
Approval Letter AGIOS PHARMS INC (Sep 28, 2026)
FDA posted an approval letter for PYRUKYND, AQVESME on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216196 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• PYRUKYND / AQVESME
ALApproval Letter
Approval Letter EISAI INC (Sep 28, 2026)
FDA posted an approval letter for LENVIMA on 2026-09-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206947 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 28, 2026
US FDA• LENVIMA

Page 34 of 152

1…32 33 34 35 36…152

Approval Letter ABBVIE INC (Sep 29, 2026)

Approval Letter AMGEN INC (Sep 29, 2026)

Approval Letter INCYTE CORP (Sep 29, 2026)

Approval Letter ADVENTAPHARMA DWC LLC (Sep 29, 2026)

Approval Letter PLANO PHARMS (Sep 29, 2026)

Approval Letter GENENTECH (Sep 29, 2026)

Tentative Approval Letter LUPIN (Sep 29, 2026)

Approval Letter KENVUE BRANDS (Sep 29, 2026)

Approval Letter MERCK SHARP DOHME (Sep 28, 2026)

Approval Letter WAYLIS THERAP (Sep 28, 2026)

Approval Letter AGIOS PHARMS INC (Sep 28, 2026)

Approval Letter EISAI INC (Sep 28, 2026)