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 1477-1488 of 1819 letters

ALApproval Letter
Approval Letter AM REGENT (Mar 16, 2026)
FDA posted an approval letter for VENOFER on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021135 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• VENOFER
ALApproval Letter
Approval Letter SANOFI-AVENTIS US (Mar 16, 2026)
FDA posted an approval letter for ADLYXIN on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 208471 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• ADLYXIN
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Mar 16, 2026)
FDA posted an approval letter for SUNLENCA on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215973, NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• SUNLENCA
ALApproval Letter
Approval Letter BIOMARIN PHARM (Mar 16, 2026)
FDA posted an approval letter for PALYNZIQ on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761079 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• PALYNZIQ
ALApproval Letter
Approval Letter INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC (Mar 16, 2026)
FDA posted an approval letter for MEDICAL AIR, USP on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221337 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• MEDICAL AIR, USP
ALApproval Letter
Approval Letter ELI LILLY AND CO (Mar 16, 2026)
FDA posted an approval letter for TRULICITY on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125469 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• TRULICITY
WLWarning Letter
Warning Letter Microbiological Testing & Consulting, LLC (Mar 16, 2026)
FDA issued a warning letter to Microbiological Testing & Consulting, LLC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 16, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter ImmunityBio, Inc. (Mar 13, 2026)
FDA issued a warning letter to ImmunityBio, Inc. concerning False & Misleading Claims/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 13, 2026
US FDA• False & Misleading Claims/Misbranded
ALApproval Letter
Approval Letter DEXCEL (Mar 12, 2026)
FDA posted an approval letter for LANSOPRAZOLE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208025 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• LANSOPRAZOLE
ALApproval Letter
Approval Letter BAYER (Mar 12, 2026)
FDA posted an approval letter for ALEVE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020204 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• ALEVE
ALApproval Letter
Approval Letter SPRINGWORKS (Mar 12, 2026)
FDA posted an approval letter for OGSIVEO on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• OGSIVEO
ALApproval Letter
Approval Letter NEXTWAVE PHARMS (Mar 12, 2026)
FDA posted an approval letter for QUILLICHEW ER on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207960 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• QUILLICHEW ER

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Approval Letter AM REGENT (Mar 16, 2026)

Approval Letter SANOFI-AVENTIS US (Mar 16, 2026)

Approval Letter GILEAD SCIENCES INC (Mar 16, 2026)

Approval Letter BIOMARIN PHARM (Mar 16, 2026)

Approval Letter INDUSTRIAL WELDING SUPPLY CO OF HARVEY INC (Mar 16, 2026)

Approval Letter ELI LILLY AND CO (Mar 16, 2026)

Warning Letter Microbiological Testing & Consulting, LLC (Mar 16, 2026)

Warning Letter ImmunityBio, Inc. (Mar 13, 2026)

Approval Letter DEXCEL (Mar 12, 2026)

Approval Letter BAYER (Mar 12, 2026)

Approval Letter SPRINGWORKS (Mar 12, 2026)

Approval Letter NEXTWAVE PHARMS (Mar 12, 2026)