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 505-516 of 1819 letters

ALApproval Letter
Approval Letter EMERGE BIOSCIENCE PTE LTD (Sep 1, 2026)
FDA posted an approval letter for YUSIMRY on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761216 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• YUSIMRY
ALApproval Letter
Approval Letter MILLA PHARMS (Sep 1, 2026)
FDA posted an approval letter for CALCIUM GLUCONATE IN SODIUM CHLORIDE on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219037 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• CALCIUM GLUCONATE IN SODIUM CHLORIDE
ALApproval Letter
Approval Letter ETON (Sep 1, 2026)
FDA posted an approval letter for HEMANGEOL on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205410 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• HEMANGEOL
ALApproval Letter
Approval Letter PHARMAESSENTIA CORP (Sep 1, 2026)
FDA posted an approval letter for BESREMI on 2026-09-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 1, 2026
US FDA• BESREMI
WLWarning Letter
Warning Letter Star Ocean Wholesale Foods, Inc. (Sep 1, 2026)
FDA issued a warning letter to Star Ocean Wholesale Foods, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. 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.
IssuedSep 1, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter O.N. Diagnostics, LLC (Sep 1, 2026)
FDA issued a warning letter to O.N. Diagnostics, LLC concerning Medical Device Reporting/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, 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.
IssuedSep 1, 2026
US FDA• Medical Device Reporting/Misbranded
WLWarning Letter
Warning Letter Happy Farm Botanicals, Inc. (Sep 1, 2026)
FDA issued a warning letter to Happy Farm Botanicals, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, 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.
IssuedSep 1, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)
FDA posted an approval letter for BIXLENVO on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221104 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• BIXLENVO
ALApproval Letter
Approval Letter SUN PHARM (Aug 28, 2026)
FDA posted an approval letter for VOBRIG on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213225 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• VOBRIG
ALApproval Letter
Approval Letter REVOLUTION MEDICINES (Aug 28, 2026)
FDA posted an approval letter for RASONQUE on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220910 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• RASONQUE
ALApproval Letter
Approval Letter PRIOVANT THERAP (Aug 28, 2026)
FDA posted an approval letter for LISRAYA on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220106 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• LISRAYA
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Aug 28, 2026)
FDA posted an approval letter for IMAAVY on 2026-08-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 28, 2026
US FDA• IMAAVY

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Approval Letter EMERGE BIOSCIENCE PTE LTD (Sep 1, 2026)

Approval Letter MILLA PHARMS (Sep 1, 2026)

Approval Letter ETON (Sep 1, 2026)

Approval Letter PHARMAESSENTIA CORP (Sep 1, 2026)

Warning Letter Star Ocean Wholesale Foods, Inc. (Sep 1, 2026)

Warning Letter O.N. Diagnostics, LLC (Sep 1, 2026)

Warning Letter Happy Farm Botanicals, Inc. (Sep 1, 2026)

Approval Letter GILEAD SCIENCES INC (Aug 28, 2026)

Approval Letter SUN PHARM (Aug 28, 2026)

Approval Letter REVOLUTION MEDICINES (Aug 28, 2026)

Approval Letter PRIOVANT THERAP (Aug 28, 2026)

Approval Letter JANSSEN BIOTECH (Aug 28, 2026)