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 1465-1476 of 1819 letters

ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 19, 2026)
FDA posted an approval letter for ICOTYDE on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220149 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• ICOTYDE
TATentative Approval Letter
Tentative Approval Letter AMNEAL (Mar 19, 2026)
FDA posted a tentative approval letter for MACITENTAN on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211000 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• MACITENTAN
ALApproval Letter
Approval Letter ABBVIE (Mar 19, 2026)
FDA posted an approval letter for COMBIGAN on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021398 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• COMBIGAN
TATentative Approval Letter
Tentative Approval Letter MSN PHARMACEUTICALS INC (Mar 19, 2026)
FDA posted a tentative approval letter for AFATINIB on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210804 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 19, 2026
US FDA• AFATINIB
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Mar 19, 2026)
FDA posted an approval letter for TRIKAFTA (COPACKAGED) on 2026-03-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212273, NDA 217660 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 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 posted an approval letter for SOLIQUA 100/33 on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 208673 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• SOLIQUA 100/33
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Mar 16, 2026)
FDA posted an approval letter for METHOTREXATE on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• METHOTREXATE
ALApproval Letter
Approval Letter NOVARTIS PHARMS CORP (Mar 16, 2026)
FDA posted an approval letter for COSENTYX on 2026-03-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125504, BLA 761349 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 16, 2026
US FDA• COSENTYX

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Approval Letter JANSSEN BIOTECH (Mar 19, 2026)

Tentative Approval Letter AMNEAL (Mar 19, 2026)

Approval Letter ABBVIE (Mar 19, 2026)

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)