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 1,503 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 865-876 of 1503 letters

ALApproval Letter
Approval Letter GENENTECH INC (May 13, 2026)
FDA issued an approval letter for TECENTRIQ HYBREZA on 2026-05-13. The source metadata identifies BLA 761347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• TECENTRIQ HYBREZA
ALApproval Letter
Approval Letter BRACCO (May 13, 2026)
FDA issued an approval letter for CARDIOGEN-82 on 2026-05-13. The source metadata identifies NDA 019414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• CARDIOGEN-82
ALApproval Letter
Approval Letter CUBIST PHARMS LLC (May 13, 2026)
FDA issued an approval letter for ZERBAXA on 2026-05-13. The source metadata identifies NDA 206829 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• ZERBAXA
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (May 13, 2026)
FDA issued an approval letter for OPDIVO on 2026-05-13. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• OPDIVO
ALApproval Letter
Approval Letter SANDOZ INC (May 13, 2026)
FDA issued an approval letter for ZIEXTENZO on 2026-05-13. The source metadata identifies BLA 761045 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• ZIEXTENZO
ALApproval Letter
Approval Letter AMGEN INC (May 13, 2026)
FDA issued an approval letter for WEZLANA on 2026-05-13. The source metadata identifies BLA 761285, BLA 761331 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• WEZLANA
ALApproval Letter
Approval Letter AMNEAL (May 13, 2026)
FDA issued an approval letter for PYRIDOSTIGMINE BROMIDE on 2026-05-13. The source metadata identifies NDA 217604 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• PYRIDOSTIGMINE BROMIDE
ALApproval Letter
Approval Letter GENENTECH INC (May 13, 2026)
FDA issued an approval letter for TECENTRIQ on 2026-05-13. The source metadata identifies BLA 761034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• TECENTRIQ
ALApproval Letter
Approval Letter B BRAUN (May 13, 2026)
FDA issued an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-13. The source metadata identifies NDA 016730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• DEXTROSE 5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter BRISTOL-MYERS SQUIBB (May 13, 2026)
FDA issued an approval letter for OPDIVO QVANTIG on 2026-05-13. The source metadata identifies BLA 761381 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 13, 2026
US FDA• OPDIVO QVANTIG
ALApproval Letter
Approval Letter NOVARTIS (May 12, 2026)
FDA issued an approval letter for DIOVAN on 2026-05-12. The source metadata identifies NDA 021283 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 12, 2026
US FDA• DIOVAN
ALApproval Letter
Approval Letter ACCORD BIOPHARMA INC. (May 12, 2026)
FDA issued an approval letter for ENNUMO on 2026-05-12. The source metadata identifies BLA 761147 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 12, 2026
US FDA• ENNUMO

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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)

Approval Letter ACCORD BIOPHARMA INC. (May 12, 2026)