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 1153-1164 of 1503 letters

TATentative Approval Letter
Tentative Approval Letter MSN PHARMACEUTICALS INC (Mar 19, 2026)
FDA issued a tentative approval letter for AFATINIB on 2026-03-19. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 19, 2026
US FDA• AFATINIB
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 19, 2026)
FDA issued an approval letter for TRIKAFTA (COPACKAGED) on 2026-03-19. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 19, 2026
US FDA• TRIKAFTA (COPACKAGED)
WLWarning Letter
Warning Letter Shang Hao Jia, Inc. (Mar 18, 2026)
FDA issued a warning letter to Shang Hao Jia, Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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 18, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Yangzhou H&R Plastic Daily Chemical Co., Ltd. (Mar 18, 2026)
FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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 18, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Schlechter Farms Inc. (Mar 18, 2026)
FDA issued a warning letter to Schlechter Farms Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedMar 18, 2026
US FDA• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
WLWarning Letter
Warning Letter 4U Health (Mar 17, 2026)
FDA issued a warning letter to 4U Health concerning Premarket Approval/Adulterated. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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 17, 2026
US FDA• Premarket Approval/Adulterated
ALApproval Letter
Approval Letter SANOFI-AVENTIS US (Mar 16, 2026)
FDA issued an approval letter for SOLIQUA 100/33 on 2026-03-16. The source metadata identifies BLA 208673 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• SOLIQUA 100/33
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Mar 16, 2026)
FDA issued an approval letter for METHOTREXATE on 2026-03-16. The source metadata identifies NDA 214121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• METHOTREXATE
ALApproval Letter
Approval Letter NOVARTIS PHARMS CORP (Mar 16, 2026)
FDA issued an approval letter for COSENTYX on 2026-03-16. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• COSENTYX
ALApproval Letter
Approval Letter AM REGENT (Mar 16, 2026)
FDA issued an approval letter for VENOFER on 2026-03-16. The source metadata identifies NDA 021135 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• VENOFER
ALApproval Letter
Approval Letter SANOFI-AVENTIS US (Mar 16, 2026)
FDA issued an approval letter for ADLYXIN on 2026-03-16. The source metadata identifies BLA 208471 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• ADLYXIN
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Mar 16, 2026)
FDA issued an approval letter for SUNLENCA on 2026-03-16. The source metadata identifies NDA 215973, NDA 215974 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 16, 2026
US FDA• SUNLENCA

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Tentative Approval Letter MSN PHARMACEUTICALS INC (Mar 19, 2026)

Approval Letter VERTEX PHARMS INC (Mar 19, 2026)

Warning Letter Shang Hao Jia, Inc. (Mar 18, 2026)

Warning Letter Yangzhou H&R Plastic Daily Chemical Co., Ltd. (Mar 18, 2026)

Warning Letter Schlechter Farms Inc. (Mar 18, 2026)

Warning Letter 4U Health (Mar 17, 2026)

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

Approval Letter ACCORD HLTHCARE (Mar 16, 2026)

Approval Letter NOVARTIS PHARMS CORP (Mar 16, 2026)

Approval Letter AM REGENT (Mar 16, 2026)

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

Approval Letter GILEAD SCIENCES INC (Mar 16, 2026)