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 961-972 of 1819 letters

ALApproval Letter
Approval Letter JANSSEN BIOTECH (Jun 11, 2026)
FDA posted an approval letter for DARZALEX on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761036 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• DARZALEX
ALApproval Letter
Approval Letter MALLINCKRODT IRELAND (Jun 11, 2026)
FDA posted an approval letter for TERLIVAZ on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• TERLIVAZ
ALApproval Letter
Approval Letter BRISTOL (Jun 11, 2026)
FDA posted an approval letter for SOTYKTU on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214958 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• SOTYKTU
ALApproval Letter
Approval Letter PFIZER (Jun 11, 2026)
FDA posted an approval letter for ZYVOX on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021130, NDA 021131, NDA 021132 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• ZYVOX
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jun 11, 2026)
FDA posted an approval letter for EBGLYSS on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• EBGLYSS
ALApproval Letter
Approval Letter EUGIA PHARMA SPECLTS (Jun 11, 2026)
FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209552 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• ARGATROBAN IN SODIUM CHLORIDE
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Jun 11, 2026)
FDA posted an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• MALARONE / MALARONE PEDIATRIC
ALApproval Letter
Approval Letter AUROBINDO PHARMA (Jun 11, 2026)
FDA posted an approval letter for CEPHALEXIN on 2026-06-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 213568 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 11, 2026
US FDA• CEPHALEXIN
ALApproval Letter
Approval Letter ACTAVIS LABS FL INC (Jun 9, 2026)
FDA posted an approval letter for RIFAXIMIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208959 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• RIFAXIMIN
ALApproval Letter
Approval Letter TEVA PHARMS USA INC (Jun 9, 2026)
FDA posted an approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211583 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ALApproval Letter
Approval Letter SANDOZ (Jun 9, 2026)
FDA posted an approval letter for MESALAMINE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219997 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• MESALAMINE
ALApproval Letter
Approval Letter METHAPHARM (Jun 9, 2026)
FDA posted an approval letter for PROVOCHOLINE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019193 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• PROVOCHOLINE

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Approval Letter JANSSEN BIOTECH (Jun 11, 2026)

Approval Letter MALLINCKRODT IRELAND (Jun 11, 2026)

Approval Letter BRISTOL (Jun 11, 2026)

Approval Letter PFIZER (Jun 11, 2026)

Approval Letter ELI LILLY AND CO (Jun 11, 2026)

Approval Letter EUGIA PHARMA SPECLTS (Jun 11, 2026)

Approval Letter GLAXOSMITHKLINE (Jun 11, 2026)

Approval Letter AUROBINDO PHARMA (Jun 11, 2026)

Approval Letter ACTAVIS LABS FL INC (Jun 9, 2026)

Approval Letter TEVA PHARMS USA INC (Jun 9, 2026)

Approval Letter SANDOZ (Jun 9, 2026)

Approval Letter METHAPHARM (Jun 9, 2026)