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 733-744 of 1503 letters

ALApproval Letter
Approval Letter EPIC PHARMA LLC (Jun 3, 2026)
FDA issued an approval letter for FUROSEMIDE on 2026-06-03. The source metadata identifies NDA 018569 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 3, 2026
US FDA• FUROSEMIDE
ALApproval Letter
Approval Letter NOVO (Jun 3, 2026)
FDA issued an approval letter for SAXENDA on 2026-06-03. The source metadata identifies NDA 206321 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 3, 2026
US FDA• SAXENDA
ALApproval Letter
Approval Letter LUPIN LIMITED (Jun 3, 2026)
FDA issued an approval letter for RANLUSPEC on 2026-06-03. The source metadata identifies BLA 761480 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 3, 2026
US FDA• RANLUSPEC
WLWarning Letter
Warning Letter BlephEx, LLC (Jun 3, 2026)
FDA issued a warning letter to BlephEx, LLC concerning Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJun 3, 2026
US FDA• Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
WLWarning Letter
Warning Letter Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (Jun 3, 2026)
FDA issued a warning letter to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/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.
IssuedJun 3, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
WLWarning Letter
Warning Letter InvaDerm, Inc. (Jun 3, 2026)
FDA issued a warning letter to InvaDerm, Inc. concerning Electronic Drug Registration and Listing System (eDRLS)/Violations. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedJun 3, 2026
US FDA• Electronic Drug Registration and Listing System (eDRLS)/Violations
ALApproval Letter
Approval Letter SABA ILAC SANAYI (Jun 2, 2026)
FDA issued an approval letter for ARFORMOTEROL TARTRATE on 2026-06-02. The source metadata identifies ANDA 218429 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• ARFORMOTEROL TARTRATE
ALApproval Letter
Approval Letter WOCKHARDT BIO AG (Jun 2, 2026)
FDA issued an approval letter for ZAYNICH on 2026-06-02. The source metadata identifies NDA 220787 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• ZAYNICH
ALApproval Letter
Approval Letter MSN (Jun 2, 2026)
FDA issued an approval letter for BRIVARACETAM on 2026-06-02. The source metadata identifies ANDA 214924 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• BRIVARACETAM
ALApproval Letter
Approval Letter FLEX PHARMA (Jun 2, 2026)
FDA issued an approval letter for CAVHANZA on 2026-06-02. The source metadata identifies NDA 217379 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• CAVHANZA
ALApproval Letter
Approval Letter SHIONOGI (Jun 2, 2026)
FDA issued an approval letter for XOCOVA on 2026-06-02. The source metadata identifies NDA 220442 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• XOCOVA
ALApproval Letter
Approval Letter NOVO (Jun 2, 2026)
FDA issued an approval letter for OZEMPIC on 2026-06-02. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• OZEMPIC

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Approval Letter EPIC PHARMA LLC (Jun 3, 2026)

Approval Letter NOVO (Jun 3, 2026)

Approval Letter LUPIN LIMITED (Jun 3, 2026)

Warning Letter BlephEx, LLC (Jun 3, 2026)

Warning Letter Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (Jun 3, 2026)

Warning Letter InvaDerm, Inc. (Jun 3, 2026)

Approval Letter SABA ILAC SANAYI (Jun 2, 2026)

Approval Letter WOCKHARDT BIO AG (Jun 2, 2026)

Approval Letter MSN (Jun 2, 2026)

Approval Letter FLEX PHARMA (Jun 2, 2026)

Approval Letter SHIONOGI (Jun 2, 2026)

Approval Letter NOVO (Jun 2, 2026)