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 1369-1380 of 1819 letters

ALApproval Letter
Approval Letter INCYTE CORP (Mar 31, 2026)
FDA posted an approval letter for ZYNYZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761334 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• ZYNYZ
ALApproval Letter
Approval Letter TEVA PHARMACEUTICALS, INC. (Mar 31, 2026)
FDA posted an approval letter for PONLIMSI on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761385 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• PONLIMSI
ALApproval Letter
Approval Letter HALEON US HOLDINGS (Mar 31, 2026)
FDA posted an approval letter for ALLI on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021887 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• ALLI
ALApproval Letter
Approval Letter STERISCIENCE (Mar 31, 2026)
FDA posted an approval letter for FOCINVEZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216686 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• FOCINVEZ
ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Mar 31, 2026)
FDA posted an approval letter for EPINEPHRINE on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220626 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• EPINEPHRINE
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Mar 31, 2026)
FDA posted an approval letter for ZEJULA on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214876 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• ZEJULA
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 31, 2026)
FDA posted an approval letter for BYOOVIZ on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• BYOOVIZ
ALApproval Letter
Approval Letter BIOGEN (Mar 31, 2026)
FDA posted an approval letter for SPINRAZA on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• SPINRAZA
ALApproval Letter
Approval Letter ACADIA PHARMS INC (Mar 31, 2026)
FDA posted an approval letter for DAYBUE on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• DAYBUE
ALApproval Letter
Approval Letter NOVO NORDISK INC (Mar 31, 2026)
FDA posted an approval letter for AWIQLI FLEXTOUCH on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• AWIQLI FLEXTOUCH
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 31, 2026)
FDA posted an approval letter for ALYFTREK on 2026-03-31. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 31, 2026
US FDA• ALYFTREK
WLWarning Letter
Warning Letter Zap Expo Center Inc. (Mar 31, 2026)
FDA issued a warning letter to Zap Expo Center Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 31, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

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Approval Letter INCYTE CORP (Mar 31, 2026)

Approval Letter TEVA PHARMACEUTICALS, INC. (Mar 31, 2026)

Approval Letter HALEON US HOLDINGS (Mar 31, 2026)

Approval Letter STERISCIENCE (Mar 31, 2026)

Approval Letter BAXTER HLTHCARE CORP (Mar 31, 2026)

Approval Letter GLAXOSMITHKLINE (Mar 31, 2026)

Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 31, 2026)

Approval Letter BIOGEN (Mar 31, 2026)

Approval Letter ACADIA PHARMS INC (Mar 31, 2026)

Approval Letter NOVO NORDISK INC (Mar 31, 2026)

Approval Letter VERTEX PHARMS INC (Mar 31, 2026)

Warning Letter Zap Expo Center Inc. (Mar 31, 2026)