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 1393-1404 of 1819 letters

ALApproval Letter
Approval Letter ARS PHARMS OPERATION (Mar 30, 2026)
FDA posted an approval letter for NEFFY on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214697 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 30, 2026
US FDA• NEFFY
ALApproval Letter
Approval Letter PFIZER (Mar 30, 2026)
FDA posted an approval letter for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 30, 2026
US FDA• CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter PFIZER (Mar 30, 2026)
FDA posted an approval letter for CLEOCIN HYDROCHLORIDE on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050162 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 30, 2026
US FDA• CLEOCIN HYDROCHLORIDE
ALApproval Letter
Approval Letter GENENTECH (Mar 30, 2026)
FDA posted an approval letter for KADCYLA on 2026-03-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125427 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 30, 2026
US FDA• KADCYLA
WLWarning Letter
Warning Letter DO&CO Aktiengesellschaft/DO&CO, Inc. (Mar 30, 2026)
FDA issued a warning letter to DO&CO Aktiengesellschaft/DO&CO, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Food safety and supplier verification, 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.
IssuedMar 30, 2026
US FDA• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
WLWarning Letter
Warning Letter Intas Pharmaceuticals Limited (Mar 30, 2026)
FDA issued a warning letter to Intas Pharmaceuticals Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Quality systems and CAPA, Manufacturing and CGMP controls, 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 30, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter JANSSEN PHARMS (Mar 27, 2026)
FDA posted an approval letter for XARELTO on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022406, NDA 215859 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• XARELTO
ALApproval Letter
Approval Letter BRISTOL (Mar 27, 2026)
FDA posted an approval letter for KRAZATI on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• KRAZATI
ALApproval Letter
Approval Letter ALKEM LABS LTD (Mar 27, 2026)
FDA posted an approval letter for MARINOL on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018651 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• MARINOL
ALApproval Letter
Approval Letter CORCEPT THERAP (Mar 27, 2026)
FDA posted an approval letter for LIFYORLI (COPACKAGED) on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220641 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• LIFYORLI (COPACKAGED)
ALApproval Letter
Approval Letter PFIZER INC (Mar 27, 2026)
FDA posted an approval letter for ELREXFIO on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761345 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• ELREXFIO
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Mar 27, 2026)
FDA posted an approval letter for WINREVAIR on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761363 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• WINREVAIR

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Approval Letter ARS PHARMS OPERATION (Mar 30, 2026)

Approval Letter PFIZER (Mar 30, 2026)

Approval Letter PFIZER (Mar 30, 2026)

Approval Letter GENENTECH (Mar 30, 2026)

Warning Letter DO&CO Aktiengesellschaft/DO&CO, Inc. (Mar 30, 2026)

Warning Letter Intas Pharmaceuticals Limited (Mar 30, 2026)

Approval Letter JANSSEN PHARMS (Mar 27, 2026)

Approval Letter BRISTOL (Mar 27, 2026)

Approval Letter ALKEM LABS LTD (Mar 27, 2026)

Approval Letter CORCEPT THERAP (Mar 27, 2026)

Approval Letter PFIZER INC (Mar 27, 2026)

Approval Letter MERCK SHARP DOHME (Mar 27, 2026)