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 637-648 of 1819 letters

ALApproval Letter
Approval Letter NOVARTIS (Aug 4, 2026)
FDA posted an approval letter for PLUVICTO on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215833 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• PLUVICTO
ALApproval Letter
Approval Letter DR REDDYS LABS SA (Aug 4, 2026)
FDA posted an approval letter for ZIMRIXBY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761376 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• ZIMRIXBY
TATentative Approval Letter
Tentative Approval Letter CMG PHARM CO LTD (Aug 4, 2026)
FDA posted a tentative approval letter for MEZOFY on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211448 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• MEZOFY
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Aug 4, 2026)
FDA posted an approval letter for HERNEXEOS on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• HERNEXEOS
ALApproval Letter
Approval Letter ACCORD HLTHCARE (Aug 4, 2026)
FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• ARGATROBAN IN SODIUM CHLORIDE
ALApproval Letter
Approval Letter RENGENERON PHARMACEUTICALS, INC. (Aug 4, 2026)
FDA posted an approval letter for LYNOZYFIC on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• LYNOZYFIC
WLWarning Letter
Warning Letter Mesquite Gourmet LLC (Aug 4, 2026)
FDA issued a warning letter to Mesquite Gourmet 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.
IssuedAug 4, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Stokes Healthcare Inc. dba Epicur Pharma (Aug 4, 2026)
FDA issued a warning letter to Stokes Healthcare Inc. dba Epicur Pharma concerning Animal Drugs/Adulterated. Deterministic full-text screening identifies discussion of 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.
IssuedAug 4, 2026
US FDA• Animal Drugs/Adulterated
WLWarning Letter
Warning Letter American Pharma Mfg. Inc. (Aug 4, 2026)
FDA issued a warning letter to American Pharma Mfg. Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedAug 4, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded
ALApproval Letter
Approval Letter SCPHARMACEUTICALS (Aug 3, 2026)
FDA posted an approval letter for FUROSCIX, FUROSCIX READYFLOW (AUTOINJECTOR) on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209988 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 3, 2026
US FDA• FUROSCIX / FUROSCIX READYFLOW (AUTOINJECTOR)
ALApproval Letter
Approval Letter ROCHE PALO (Aug 3, 2026)
FDA posted an approval letter for CELLCEPT on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050722, NDA 050723, NDA 050758, NDA 050759 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 3, 2026
US FDA• CELLCEPT
TATentative Approval Letter
Tentative Approval Letter APOTEX (Aug 3, 2026)
FDA posted a tentative approval letter for Ruxolitinib on 2026-08-03. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219660 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 3, 2026
US FDA• Ruxolitinib

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Approval Letter NOVARTIS (Aug 4, 2026)

Approval Letter DR REDDYS LABS SA (Aug 4, 2026)

Tentative Approval Letter CMG PHARM CO LTD (Aug 4, 2026)

Approval Letter BOEHRINGER INGELHEIM (Aug 4, 2026)

Approval Letter ACCORD HLTHCARE (Aug 4, 2026)

Approval Letter RENGENERON PHARMACEUTICALS, INC. (Aug 4, 2026)

Warning Letter Mesquite Gourmet LLC (Aug 4, 2026)

Warning Letter Stokes Healthcare Inc. dba Epicur Pharma (Aug 4, 2026)

Warning Letter American Pharma Mfg. Inc. (Aug 4, 2026)

Approval Letter SCPHARMACEUTICALS (Aug 3, 2026)

Approval Letter ROCHE PALO (Aug 3, 2026)

Tentative Approval Letter APOTEX (Aug 3, 2026)