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 625-636 of 1503 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Jun 16, 2026)
FDA issued an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 16, 2026
US FDA• ZYRTEC ALLERGY / ZYRTEC HIVES
ALApproval Letter
Approval Letter AMPHASTAR PHARMS INC (Jun 16, 2026)
FDA issued an approval letter for REXTOVY on 2026-06-16. The source metadata identifies NDA 208969 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 16, 2026
US FDA• REXTOVY
ALApproval Letter
Approval Letter AZURITY (Jun 16, 2026)
FDA issued an approval letter for WIDAPLIK on 2026-06-16. The source metadata identifies NDA 219423 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 16, 2026
US FDA• WIDAPLIK
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jun 16, 2026)
FDA issued an approval letter for WELIREG on 2026-06-16. The source metadata identifies NDA 215383 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 16, 2026
US FDA• WELIREG
WLWarning Letter
Warning Letter Diamond Distributions LLC (Jun 16, 2026)
FDA issued a warning letter to Diamond Distributions LLC 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.
IssuedJun 16, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter HOFFMANN-LA ROCHE (Jun 15, 2026)
FDA issued an approval letter for ALECENSA on 2026-06-15. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 15, 2026
US FDA• ALECENSA
ALApproval Letter
Approval Letter BAXTER HLTHCARE (Jun 15, 2026)
FDA issued an approval letter for DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE 10% IN PLASTIC CONTAINER on 2026-06-15. The source metadata identifies NDA 016673, NDA 016694 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 15, 2026
US FDA• DEXTROSE 5% IN PLASTIC CONTAINER / DEXTROSE 10% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter ASTRAZENECA AB (Jun 15, 2026)
FDA issued an approval letter for BAXFENDY on 2026-06-15. The source metadata identifies NDA 219878 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 15, 2026
US FDA• BAXFENDY
ALApproval Letter
Approval Letter PROVENTION BIO INC (Jun 15, 2026)
FDA issued an approval letter for TZIELD on 2026-06-15. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 15, 2026
US FDA• TZIELD
WLWarning Letter
Warning Letter Life & Food Inc. (Jun 15, 2026)
FDA issued a warning letter to Life & Food 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.
IssuedJun 15, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Happiest Baby, Inc. (Jun 15, 2026)
FDA issued a warning letter to Happiest Baby, Inc. concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic source-metadata screening identifies discussion of 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.
IssuedJun 15, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
WLWarning Letter
Warning Letter Huons Co., Ltd. (Jun 15, 2026)
FDA issued a warning letter to Huons Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 15, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

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Approval Letter KENVUE BRANDS (Jun 16, 2026)

Approval Letter AMPHASTAR PHARMS INC (Jun 16, 2026)

Approval Letter AZURITY (Jun 16, 2026)

Approval Letter MERCK SHARP DOHME (Jun 16, 2026)

Warning Letter Diamond Distributions LLC (Jun 16, 2026)

Approval Letter HOFFMANN-LA ROCHE (Jun 15, 2026)

Approval Letter BAXTER HLTHCARE (Jun 15, 2026)

Approval Letter ASTRAZENECA AB (Jun 15, 2026)

Approval Letter PROVENTION BIO INC (Jun 15, 2026)

Warning Letter Life & Food Inc. (Jun 15, 2026)

Warning Letter Happiest Baby, Inc. (Jun 15, 2026)

Warning Letter Huons Co., Ltd. (Jun 15, 2026)