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 517-528 of 1819 letters

ALApproval Letter
Approval Letter NOVO (Aug 28, 2026)
FDA posted an approval letter for OZEMPIC on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• OZEMPIC
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)
FDA posted an approval letter for BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221443 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)
FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• SUNLENCA
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)
FDA posted an approval letter for SUNLENCA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215973 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• SUNLENCA
ALApproval Letter
Approval Letter ELI LILLY AND CO (Aug 28, 2026)
FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN
ALApproval Letter
Approval Letter CURIUM (Aug 28, 2026)
FDA posted an approval letter for ULTRATAG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019981 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• ULTRATAG
ALApproval Letter
Approval Letter LINDE GAS EQUIP (Aug 28, 2026)
FDA posted an approval letter for NITROUS OXIDE, USP on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221892 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• NITROUS OXIDE, USP
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Aug 28, 2026)
FDA posted an approval letter for GATTEX KIT on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203441 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• GATTEX KIT
WLWarning Letter
Warning Letter Tipical Latin Food, Corp. DBA La Pradera (Aug 28, 2026)
FDA issued a warning letter to Tipical Latin Food, Corp. DBA La Pradera concerning CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, 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.
IssuedAug 28, 2026
US FDA• CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
ALApproval Letter
Approval Letter JAZZ PHARMS (Aug 27, 2026)
FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 27, 2026
US FDA• ZIIHERA
ALApproval Letter
Approval Letter JAZZ PHARMS (Aug 27, 2026)
FDA posted an approval letter for ZIIHERA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761416 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 27, 2026
US FDA• ZIIHERA
ALApproval Letter
Approval Letter BEIGENE (Aug 27, 2026)
FDA posted an approval letter for TEVIMBRA on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 27, 2026
US FDA• TEVIMBRA

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Approval Letter NOVO (Aug 28, 2026)

Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)

Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)

Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)

Approval Letter ELI LILLY AND CO (Aug 28, 2026)

Approval Letter CURIUM (Aug 28, 2026)

Approval Letter LINDE GAS EQUIP (Aug 28, 2026)

Approval Letter TAKEDA PHARMS USA (Aug 28, 2026)

Warning Letter Tipical Latin Food, Corp. DBA La Pradera (Aug 28, 2026)

Approval Letter JAZZ PHARMS (Aug 27, 2026)

Approval Letter JAZZ PHARMS (Aug 27, 2026)

Approval Letter BEIGENE (Aug 27, 2026)