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 1489-1500 of 1819 letters

ALApproval Letter
Approval Letter KINIKSA PHARMACEUTICALS (UK), LTD. (Mar 12, 2026)
FDA posted an approval letter for ARCALYST on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125249 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• ARCALYST
ALApproval Letter
Approval Letter ABBVIE (Mar 12, 2026)
FDA posted an approval letter for OZURDEX on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022315 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• OZURDEX
ALApproval Letter
Approval Letter AYRMID PHARMA (Mar 12, 2026)
FDA posted an approval letter for APHEXDA on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217159 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• APHEXDA
ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Mar 12, 2026)
FDA posted an approval letter for DOXIL (LIPOSOMAL) on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050718 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• DOXIL (LIPOSOMAL)
ALApproval Letter
Approval Letter AYTU (Mar 12, 2026)
FDA posted an approval letter for KARBINAL ER on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022556 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 12, 2026
US FDA• KARBINAL ER
ALApproval Letter
Approval Letter DEXCEL (Mar 12, 2026)
FDA posted an approval letter for OMEPRAZOLE on 2026-03-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 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 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.
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 full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedMar 11, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
ALApproval Letter
Approval Letter B BRAUN (Mar 10, 2026)
FDA posted an approval letter for SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-03-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 10, 2026
US FDA• SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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Approval Letter KINIKSA PHARMACEUTICALS (UK), LTD. (Mar 12, 2026)

Approval Letter ABBVIE (Mar 12, 2026)

Approval Letter AYRMID PHARMA (Mar 12, 2026)

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)