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 1537-1548 of 1819 letters

ALApproval Letter
Approval Letter ALEMBIC (Mar 3, 2026)
FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217295, ANDA 217676 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter FRESENIUS KABI USA (Mar 3, 2026)
FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 040278, ANDA 040279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter NOVO NORDISK INC (Mar 3, 2026)
FDA posted an approval letter for SOGROYA on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761156 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• SOGROYA
ALApproval Letter
Approval Letter MACLEODS PHARMS (Mar 3, 2026)
FDA posted an approval letter for DILTIAZEM HYDROCHLORIDE on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218744 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• DILTIAZEM HYDROCHLORIDE
ALApproval Letter
Approval Letter CUBIST PHARMS LLC (Mar 3, 2026)
FDA posted an approval letter for SIVEXTRO on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205435, NDA 205436 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• SIVEXTRO
ALApproval Letter
Approval Letter ASCENDIS (Mar 3, 2026)
FDA posted an approval letter for YUVIWEL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219164 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• YUVIWEL
ALApproval Letter
Approval Letter KINDOS (Mar 3, 2026)
FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215699, ANDA 216494 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter JANSSEN PRODS (Mar 3, 2026)
FDA posted an approval letter for PREZCOBIX PED, PREZCOBIX on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220092 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• PREZCOBIX PED / PREZCOBIX
ALApproval Letter
Approval Letter INGENUS PHARMS LLC (Mar 3, 2026)
FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 209219, ANDA 209271 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Mar 3, 2026)
FDA posted an approval letter for FLUOROURACIL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 040743, ANDA 040798 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• FLUOROURACIL
ALApproval Letter
Approval Letter CELGENE CORP (Mar 3, 2026)
FDA posted an approval letter for REBLOZYL on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761136 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• REBLOZYL
ALApproval Letter
Approval Letter ALMATICA (Mar 3, 2026)
FDA posted an approval letter for DULOXETINE HYDROCHLORIDE on 2026-03-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219131 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 3, 2026
US FDA• DULOXETINE HYDROCHLORIDE

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Approval Letter ALEMBIC (Mar 3, 2026)

Approval Letter FRESENIUS KABI USA (Mar 3, 2026)

Approval Letter NOVO NORDISK INC (Mar 3, 2026)

Approval Letter MACLEODS PHARMS (Mar 3, 2026)

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)