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 1177-1188 of 1503 letters

ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Mar 12, 2026)
FDA issued an approval letter for DOXIL (LIPOSOMAL) on 2026-03-12. The source metadata identifies NDA 050718 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 12, 2026
US FDA• DOXIL (LIPOSOMAL)
ALApproval Letter
Approval Letter AYTU (Mar 12, 2026)
FDA issued an approval letter for KARBINAL ER on 2026-03-12. The source metadata identifies NDA 022556 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 12, 2026
US FDA• KARBINAL ER
ALApproval Letter
Approval Letter DEXCEL (Mar 12, 2026)
FDA issued an approval letter for OMEPRAZOLE on 2026-03-12. The source metadata identifies NDA 209400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 12, 2026
US FDA• OMEPRAZOLE
WLWarning Letter
Warning Letter Patcos Cosmetics Pvt. Ltd. (Mar 12, 2026)
FDA issued a warning letter to Patcos Cosmetics Pvt. Ltd. concerning Finished Drug Products/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 12, 2026
US FDA• Finished Drug Products/Adulterated
WLWarning Letter
Warning Letter Adnan Dahdul, MD (Mar 12, 2026)
FDA issued a warning letter to Adnan Dahdul, MD concerning Clinical Investigator/BIMO. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, 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 12, 2026
US FDA• Clinical Investigator/BIMO
WLWarning Letter
Warning Letter ISA Produce Corporation (Mar 12, 2026)
FDA issued a warning letter to ISA Produce Corporation 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 12, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter OraLabs, Inc. (Mar 11, 2026)
FDA issued a warning letter to OraLabs, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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 11, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Flowchem Pharma Private Limited (Mar 11, 2026)
FDA issued a warning letter to Flowchem Pharma Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 11, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
ALApproval Letter
Approval Letter B BRAUN (Mar 10, 2026)
FDA issued an approval letter for SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-03-10. The source metadata identifies NDA 016733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 10, 2026
US FDA• SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter NEXTWAVE (Mar 10, 2026)
FDA issued an approval letter for QUILLIVANT XR on 2026-03-10. The source metadata identifies NDA 202100 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 10, 2026
US FDA• QUILLIVANT XR
ALApproval Letter
Approval Letter SUPERNUS PHARMS (Mar 9, 2026)
FDA issued an approval letter for TROKENDI XR on 2026-03-09. The source metadata identifies NDA 201635 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• TROKENDI XR
ALApproval Letter
Approval Letter JANSSEN PHARMS (Mar 9, 2026)
FDA issued an approval letter for TOPAMAX, TOPAMAX SPRINKLE on 2026-03-09. The source metadata identifies NDA 020505, NDA 020844 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 9, 2026
US FDA• TOPAMAX / TOPAMAX SPRINKLE

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Approval Letter BAXTER HLTHCARE CORP (Mar 12, 2026)

Approval Letter AYTU (Mar 12, 2026)

Approval Letter DEXCEL (Mar 12, 2026)

Warning Letter Patcos Cosmetics Pvt. Ltd. (Mar 12, 2026)

Warning Letter Adnan Dahdul, MD (Mar 12, 2026)

Warning Letter ISA Produce Corporation (Mar 12, 2026)

Warning Letter OraLabs, Inc. (Mar 11, 2026)

Warning Letter Flowchem Pharma Private Limited (Mar 11, 2026)

Approval Letter B BRAUN (Mar 10, 2026)

Approval Letter NEXTWAVE (Mar 10, 2026)

Approval Letter SUPERNUS PHARMS (Mar 9, 2026)

Approval Letter JANSSEN PHARMS (Mar 9, 2026)