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 493-504 of 1819 letters

ALApproval Letter
Approval Letter XTM CONSULTING (Sep 2, 2026)
FDA posted an approval letter for LOPRESSOR on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218698 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• LOPRESSOR
ALApproval Letter
Approval Letter PHARMAESSENTIA CORP (Sep 2, 2026)
FDA posted an approval letter for BESREMI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• BESREMI
ALApproval Letter
Approval Letter COHERUS BIOSCIENCES INC (Sep 2, 2026)
FDA posted an approval letter for LOQTORZI on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761240 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• LOQTORZI
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Sep 2, 2026)
FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)
ALApproval Letter
Approval Letter PFIZER (Sep 2, 2026)
FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• CLEOCIN HYDROCHLORIDE
ALApproval Letter
Approval Letter BAXTER HLTHCARE (Sep 2, 2026)
FDA posted an approval letter for BACTOCILL IN PLASTIC CONTAINER on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050640 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• BACTOCILL IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter CHECKPOINT THERAPEUTICS INC (Sep 2, 2026)
FDA posted an approval letter for UNLOXCYT on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761297 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• UNLOXCYT
ALApproval Letter
Approval Letter ASTRAZENECA AB (Sep 2, 2026)
FDA posted an approval letter for IMJUDO on 2026-09-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761289 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 2, 2026
US FDA• IMJUDO
WLWarning Letter
Warning Letter TCI Co., Ltd BioCosme PABP BRANCH (Sep 2, 2026)
FDA issued a warning letter to TCI Co., Ltd BioCosme PABP BRANCH concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedSep 2, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter ELI LILLY AND CO (Sep 1, 2026)
FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866, NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN
ALApproval Letter
Approval Letter TAKEDA PHARMS AM (Sep 1, 2026)
FDA posted an approval letter for MIMRYLO on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220605 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• MIMRYLO
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Sep 1, 2026)
FDA posted an approval letter for STELARA on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761044, BLA 125261 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• STELARA

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Approval Letter XTM CONSULTING (Sep 2, 2026)

Approval Letter PHARMAESSENTIA CORP (Sep 2, 2026)

Approval Letter COHERUS BIOSCIENCES INC (Sep 2, 2026)

Approval Letter GILEAD SCIENCES INC (Sep 2, 2026)

Approval Letter PFIZER (Sep 2, 2026)

Approval Letter BAXTER HLTHCARE (Sep 2, 2026)

Approval Letter CHECKPOINT THERAPEUTICS INC (Sep 2, 2026)

Approval Letter ASTRAZENECA AB (Sep 2, 2026)

Warning Letter TCI Co., Ltd BioCosme PABP BRANCH (Sep 2, 2026)

Approval Letter ELI LILLY AND CO (Sep 1, 2026)

Approval Letter TAKEDA PHARMS AM (Sep 1, 2026)

Approval Letter JANSSEN BIOTECH (Sep 1, 2026)