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 1249-1260 of 1503 letters

ALApproval Letter
Approval Letter MERZ PHARMS (Mar 2, 2026)
FDA issued an approval letter for Xeomin on 2026-03-02. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 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 issued an approval letter for ZIOPTAN on 2026-02-27. The source metadata identifies NDA 202514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• ZIOPTAN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Feb 27, 2026)
FDA issued an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-02-27. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter NOVO (Feb 27, 2026)
FDA issued an approval letter for SAXENDA on 2026-02-27. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• SAXENDA
ALApproval Letter
Approval Letter NOVO (Feb 27, 2026)
FDA issued an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-02-27. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Feb 27, 2026)
FDA issued an approval letter for ENTYVIO on 2026-02-27. The source metadata identifies BLA 125476, BLA 761133 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• ENTYVIO
ALApproval Letter
Approval Letter ETON (Feb 27, 2026)
FDA issued an approval letter for DESMODA on 2026-02-27. The source metadata identifies NDA 219873 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• DESMODA
ALApproval Letter
Approval Letter ARS PHARMS OPERATION (Feb 27, 2026)
FDA issued an approval letter for NEFFY on 2026-02-27. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• NEFFY
ALApproval Letter
Approval Letter CHIESI (Feb 27, 2026)
FDA issued an approval letter for JUXTAPID on 2026-02-27. The source metadata identifies NDA 203858 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 27, 2026
US FDA• JUXTAPID
WLWarning Letter
Warning Letter thesnuslife.com (Feb 27, 2026)
FDA issued a warning letter to thesnuslife.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter snushaven.com (Feb 27, 2026)
FDA issued a warning letter to snushaven.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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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)

Approval Letter ARS PHARMS OPERATION (Feb 27, 2026)

Approval Letter CHIESI (Feb 27, 2026)

Warning Letter thesnuslife.com (Feb 27, 2026)

Warning Letter snushaven.com (Feb 27, 2026)