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 565-576 of 1819 letters

ALApproval Letter
Approval Letter INDIVIOR (Aug 18, 2026)
FDA posted an approval letter for SUBOXONE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022410 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• SUBOXONE
ALApproval Letter
Approval Letter IPSEN (Aug 18, 2026)
FDA posted an approval letter for IQIRVO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218860 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• IQIRVO
ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Aug 18, 2026)
FDA posted an approval letter for SODIUM BICARBONATE on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218524 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• SODIUM BICARBONATE
ALApproval Letter
Approval Letter HOFFMANN-LA ROCHE (Aug 18, 2026)
FDA posted an approval letter for ALECENSA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208434 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• ALECENSA
ALApproval Letter
Approval Letter HORIZON PHARMA (Aug 18, 2026)
FDA posted an approval letter for KRYSTEXXA on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• KRYSTEXXA
ALApproval Letter
Approval Letter LIB THERAPEUTICS, INC. (Aug 18, 2026)
FDA posted an approval letter for LEROCHOL on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761427 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• LEROCHOL
ALApproval Letter
Approval Letter EDENBRIDGE PHARMS (Aug 18, 2026)
FDA posted an approval letter for ZUBSOLV on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204242 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• ZUBSOLV
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Aug 18, 2026)
FDA posted an approval letter for JASCAYD on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• JASCAYD
ALApproval Letter
Approval Letter ASTRAZENECA AB (Aug 18, 2026)
FDA posted an approval letter for SAPHNELO on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761123 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• SAPHNELO
ALApproval Letter
Approval Letter BIOCON BIOLOGICS INC (Aug 18, 2026)
FDA posted an approval letter for YESINTEK on 2026-08-18. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761406 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 18, 2026
US FDA• YESINTEK
WLWarning Letter
Warning Letter B&P Mutual Corp (Aug 18, 2026)
FDA issued a warning letter to B&P Mutual Corp 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 18, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Shoolin Pharma Chem LLP (Aug 18, 2026)
FDA issued a warning letter to Shoolin Pharma Chem LLP concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Data integrity and records, 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.
IssuedAug 18, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

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Approval Letter INDIVIOR (Aug 18, 2026)

Approval Letter IPSEN (Aug 18, 2026)

Approval Letter BAXTER HLTHCARE CORP (Aug 18, 2026)

Approval Letter HOFFMANN-LA ROCHE (Aug 18, 2026)

Approval Letter HORIZON PHARMA (Aug 18, 2026)

Approval Letter LIB THERAPEUTICS, INC. (Aug 18, 2026)

Approval Letter EDENBRIDGE PHARMS (Aug 18, 2026)

Approval Letter BOEHRINGER INGELHEIM (Aug 18, 2026)

Approval Letter ASTRAZENECA AB (Aug 18, 2026)

Approval Letter BIOCON BIOLOGICS INC (Aug 18, 2026)

Warning Letter B&P Mutual Corp (Aug 18, 2026)

Warning Letter Shoolin Pharma Chem LLP (Aug 18, 2026)