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 1561-1572 of 1819 letters

ALApproval Letter
Approval Letter GENSCO (Mar 2, 2026)
FDA posted an approval letter for RIZAFILM on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 2, 2026
US FDA• RIZAFILM
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)
FDA posted an approval letter for JASCAYD on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 2, 2026
US FDA• JASCAYD
ALApproval Letter
Approval Letter XCOVERY (Mar 2, 2026)
FDA posted an approval letter for ENSACOVE on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 2, 2026
US FDA• ENSACOVE
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)
FDA posted an approval letter for HERNEXEOS on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 2, 2026
US FDA• HERNEXEOS
ALApproval Letter
Approval Letter MERZ PHARMS (Mar 2, 2026)
FDA posted an approval letter for Xeomin on 2026-03-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 2, 2026
US FDA• Xeomin
WLWarning Letter
Warning Letter NSE Products, Inc. DBA Nu Skin Enterprises, Inc. (Mar 2, 2026)
FDA issued a warning letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 2, 2026
US FDA• Electronic Drug Registration and Listing System (eDRLS)/Violations
ALApproval Letter
Approval Letter THEA PHARMA (Feb 27, 2026)
FDA posted an approval letter for ZIOPTAN on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• ZIOPTAN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Feb 27, 2026)
FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter NOVO (Feb 27, 2026)
FDA posted an approval letter for SAXENDA on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• SAXENDA
ALApproval Letter
Approval Letter NOVO (Feb 27, 2026)
FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Feb 27, 2026)
FDA posted an approval letter for ENTYVIO on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125476, BLA 761133 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• ENTYVIO
ALApproval Letter
Approval Letter ETON (Feb 27, 2026)
FDA posted an approval letter for DESMODA on 2026-02-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219873 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 27, 2026
US FDA• DESMODA

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Approval Letter GENSCO (Mar 2, 2026)

Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)

Approval Letter XCOVERY (Mar 2, 2026)

Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)

Approval Letter MERZ PHARMS (Mar 2, 2026)

Warning Letter NSE Products, Inc. DBA Nu Skin Enterprises, Inc. (Mar 2, 2026)

Approval Letter THEA PHARMA (Feb 27, 2026)

Approval Letter ELI LILLY AND CO (Feb 27, 2026)

Approval Letter NOVO (Feb 27, 2026)

Approval Letter NOVO (Feb 27, 2026)

Approval Letter TAKEDA PHARMS USA (Feb 27, 2026)

Approval Letter ETON (Feb 27, 2026)