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 1177-1188 of 1819 letters

ALApproval Letter
Approval Letter MERCK SHARP DOHME (May 13, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter GENENTECH INC (May 13, 2026)
FDA posted an approval letter for TECENTRIQ HYBREZA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• TECENTRIQ HYBREZA
ALApproval Letter
Approval Letter BRACCO (May 13, 2026)
FDA posted an approval letter for CARDIOGEN-82 on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• CARDIOGEN-82
ALApproval Letter
Approval Letter CUBIST PHARMS LLC (May 13, 2026)
FDA posted an approval letter for ZERBAXA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206829 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• ZERBAXA
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (May 13, 2026)
FDA posted an approval letter for OPDIVO on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• OPDIVO
ALApproval Letter
Approval Letter SANDOZ INC (May 13, 2026)
FDA posted an approval letter for ZIEXTENZO on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761045 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• ZIEXTENZO
ALApproval Letter
Approval Letter AMGEN INC (May 13, 2026)
FDA posted an approval letter for WEZLANA on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761285, BLA 761331 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• WEZLANA
ALApproval Letter
Approval Letter AMNEAL (May 13, 2026)
FDA posted an approval letter for PYRIDOSTIGMINE BROMIDE on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• PYRIDOSTIGMINE BROMIDE
ALApproval Letter
Approval Letter GENENTECH INC (May 13, 2026)
FDA posted an approval letter for TECENTRIQ on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• TECENTRIQ
ALApproval Letter
Approval Letter B BRAUN (May 13, 2026)
FDA posted an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• DEXTROSE 5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter BRISTOL-MYERS SQUIBB (May 13, 2026)
FDA posted an approval letter for OPDIVO QVANTIG on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761381 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• OPDIVO QVANTIG
ALApproval Letter
Approval Letter NOVARTIS (May 12, 2026)
FDA posted an approval letter for DIOVAN on 2026-05-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021283 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 12, 2026
US FDA• DIOVAN

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Approval Letter MERCK SHARP DOHME (May 13, 2026)

Approval Letter GENENTECH INC (May 13, 2026)

Approval Letter BRACCO (May 13, 2026)

Approval Letter CUBIST PHARMS LLC (May 13, 2026)

Approval Letter BRISTOL MYERS SQUIBB (May 13, 2026)

Approval Letter SANDOZ INC (May 13, 2026)

Approval Letter AMGEN INC (May 13, 2026)

Approval Letter AMNEAL (May 13, 2026)

Approval Letter GENENTECH INC (May 13, 2026)

Approval Letter B BRAUN (May 13, 2026)

Approval Letter BRISTOL-MYERS SQUIBB (May 13, 2026)

Approval Letter NOVARTIS (May 12, 2026)