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 673-684 of 1819 letters

ALApproval Letter
Approval Letter ABBVIE (Jul 27, 2026)
FDA posted an approval letter for NORVIR on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022417, NDA 209512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 27, 2026
US FDA• NORVIR
ALApproval Letter
Approval Letter AETERNA ZENTARIS (Jul 27, 2026)
FDA posted an approval letter for MACRILEN on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205598 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 27, 2026
US FDA• MACRILEN
ALApproval Letter
Approval Letter SANDOZ INC (Jul 27, 2026)
FDA posted an approval letter for TYRUKO on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761322 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 27, 2026
US FDA• TYRUKO
ALApproval Letter
Approval Letter ABBVIE (Jul 27, 2026)
FDA posted an approval letter for KALETRA on 2026-07-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021906, NDA 021251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 27, 2026
US FDA• KALETRA
WLWarning Letter
Warning Letter Maria E. De La Torre Silva, M.D. (Jul 27, 2026)
FDA issued a warning letter to Maria E. De La Torre Silva, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 27, 2026
US FDA• Clinical Investigator
WLWarning Letter
Warning Letter Vargas Produce LLC (Jul 27, 2026)
FDA issued a warning letter to Vargas Produce 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.
IssuedJul 27, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Woodbine Products Company Inc. (Jul 27, 2026)
FDA issued a warning letter to Woodbine Products Company Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, 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.
IssuedJul 27, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter AUROBINDO PHARMA LTD (Jul 24, 2026)
FDA posted an approval letter for BUPROPION HYDROCHLORIDE on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216051 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• BUPROPION HYDROCHLORIDE
ALApproval Letter
Approval Letter NUVALENT (Jul 24, 2026)
FDA posted an approval letter for JIDEYTRO on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220185 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• JIDEYTRO
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Jul 24, 2026)
FDA posted an approval letter for REVLIMID on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021880 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• REVLIMID
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 24, 2026)
FDA posted an approval letter for CHILDREN'S MOTRIN, MOTRIN IB on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020516 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• CHILDREN'S MOTRIN / MOTRIN IB
ALApproval Letter
Approval Letter LANTHEUS (Jul 24, 2026)
FDA posted an approval letter for NEURACEQ on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• NEURACEQ

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Approval Letter ABBVIE (Jul 27, 2026)

Approval Letter AETERNA ZENTARIS (Jul 27, 2026)

Approval Letter SANDOZ INC (Jul 27, 2026)

Approval Letter ABBVIE (Jul 27, 2026)

Warning Letter Maria E. De La Torre Silva, M.D. (Jul 27, 2026)

Warning Letter Vargas Produce LLC (Jul 27, 2026)

Warning Letter Woodbine Products Company Inc. (Jul 27, 2026)

Approval Letter AUROBINDO PHARMA LTD (Jul 24, 2026)

Approval Letter NUVALENT (Jul 24, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Jul 24, 2026)

Approval Letter KENVUE BRANDS (Jul 24, 2026)

Approval Letter LANTHEUS (Jul 24, 2026)