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 1225-1236 of 1503 letters

ALApproval Letter
Approval Letter CUBIST PHARMS LLC (Mar 3, 2026)
FDA issued an approval letter for SIVEXTRO on 2026-03-03. The source metadata identifies NDA 205435, NDA 205436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• SIVEXTRO
ALApproval Letter
Approval Letter ASCENDIS (Mar 3, 2026)
FDA issued an approval letter for YUVIWEL on 2026-03-03. The source metadata identifies NDA 219164 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• YUVIWEL
ALApproval Letter
Approval Letter KINDOS (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 215699, ANDA 216494 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter JANSSEN PRODS (Mar 3, 2026)
FDA issued an approval letter for PREZCOBIX PED, PREZCOBIX on 2026-03-03. The source metadata identifies NDA 220092 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• PREZCOBIX PED / PREZCOBIX
ALApproval Letter
Approval Letter INGENUS PHARMS LLC (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 209219, ANDA 209271 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040743, ANDA 040798 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter CELGENE CORP (Mar 3, 2026)
FDA issued an approval letter for REBLOZYL on 2026-03-03. The source metadata identifies BLA 761136 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• REBLOZYL
ALApproval Letter
Approval Letter ALMATICA (Mar 3, 2026)
FDA issued an approval letter for DULOXETINE HYDROCHLORIDE on 2026-03-03. The source metadata identifies NDA 219131 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• DULOXETINE HYDROCHLORIDE
ALApproval Letter
Approval Letter JAZZ (Mar 3, 2026)
FDA issued an approval letter for ZEPZELCA on 2026-03-03. The source metadata identifies NDA 213702 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• ZEPZELCA
ALApproval Letter
Approval Letter GLAND (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 210123, ANDA 210124 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter HUMANWELL PURACAP (Mar 3, 2026)
FDA issued an approval letter for CALCITRIOL on 2026-03-03. The source metadata identifies ANDA 219796 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• CALCITRIOL
ALApproval Letter
Approval Letter VALEANT LUXEMBOURG (Mar 3, 2026)
FDA issued an approval letter for SILIQ on 2026-03-03. The source metadata identifies BLA 761032 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• SILIQ

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Approval Letter CUBIST PHARMS LLC (Mar 3, 2026)

Approval Letter ASCENDIS (Mar 3, 2026)

Approval Letter KINDOS (Mar 3, 2026)

Approval Letter JANSSEN PRODS (Mar 3, 2026)

Approval Letter INGENUS PHARMS LLC (Mar 3, 2026)

Approval Letter ACCORD HLTHCARE (Mar 3, 2026)

Approval Letter CELGENE CORP (Mar 3, 2026)

Approval Letter ALMATICA (Mar 3, 2026)

Approval Letter JAZZ (Mar 3, 2026)

Approval Letter GLAND (Mar 3, 2026)

Approval Letter HUMANWELL PURACAP (Mar 3, 2026)

Approval Letter VALEANT LUXEMBOURG (Mar 3, 2026)