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 1057-1068 of 1503 letters

ALApproval Letter
Approval Letter STERISCIENCE (Mar 31, 2026)
FDA issued an approval letter for FOCINVEZ on 2026-03-31. The source metadata identifies NDA 216686 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• FOCINVEZ
ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Mar 31, 2026)
FDA issued an approval letter for EPINEPHRINE on 2026-03-31. The source metadata identifies NDA 220626 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• EPINEPHRINE
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Mar 31, 2026)
FDA issued an approval letter for ZEJULA on 2026-03-31. The source metadata identifies NDA 214876 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• ZEJULA
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 31, 2026)
FDA issued an approval letter for BYOOVIZ on 2026-03-31. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• BYOOVIZ
ALApproval Letter
Approval Letter BIOGEN (Mar 31, 2026)
FDA issued an approval letter for SPINRAZA on 2026-03-31. The source metadata identifies NDA 209531 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• SPINRAZA
ALApproval Letter
Approval Letter ACADIA PHARMS INC (Mar 31, 2026)
FDA issued an approval letter for DAYBUE on 2026-03-31. The source metadata identifies NDA 217026 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• DAYBUE
ALApproval Letter
Approval Letter NOVO NORDISK INC (Mar 31, 2026)
FDA issued an approval letter for AWIQLI FLEXTOUCH on 2026-03-31. The source metadata identifies BLA 761326 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 31, 2026
US FDA• AWIQLI FLEXTOUCH
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 31, 2026)
FDA issued an approval letter for ALYFTREK on 2026-03-31. The source metadata identifies NDA 218730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 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 source-metadata 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)
WLWarning Letter
Warning Letter PekCura Labs (Mar 31, 2026)
FDA issued a warning letter to PekCura Labs concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. 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• Unapproved New Drugs Sold Over the Internet
WLWarning Letter
Warning Letter Gram Peptides (Mar 31, 2026)
FDA issued a warning letter to Gram Peptides concerning Unapproved New Drugs Sold Over the Internet. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. 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• Unapproved New Drugs Sold Over the Internet
WLWarning Letter
Warning Letter Global Tobacco, LLC (Mar 31, 2026)
FDA issued a warning letter to Global Tobacco, LLC 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.
IssuedMar 31, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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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)

Warning Letter PekCura Labs (Mar 31, 2026)

Warning Letter Gram Peptides (Mar 31, 2026)

Warning Letter Global Tobacco, LLC (Mar 31, 2026)