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 625-636 of 1819 letters

ALApproval Letter
Approval Letter PRAGMA (Aug 6, 2026)
FDA posted an approval letter for KEFLEX on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050405 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• KEFLEX
ALApproval Letter
Approval Letter ALVOGEN (Aug 6, 2026)
FDA posted an approval letter for BONSITY on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• BONSITY
ALApproval Letter
Approval Letter ASCENDIS PHARMA BONE (Aug 6, 2026)
FDA posted an approval letter for YORVIPATH on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216490 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• YORVIPATH
ALApproval Letter
Approval Letter ALMAJECT (Aug 6, 2026)
FDA posted an approval letter for TERIPARATIDE on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218771 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• TERIPARATIDE
ALApproval Letter
Approval Letter AMGEN (Aug 6, 2026)
FDA posted an approval letter for NEULASTA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125031 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• NEULASTA
ALApproval Letter
Approval Letter CELLTRION (Aug 6, 2026)
FDA posted an approval letter for YUFLYMA on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761219 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• YUFLYMA
ALApproval Letter
Approval Letter LILLY (Aug 6, 2026)
FDA posted an approval letter for FORTEO on 2026-08-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021318 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 6, 2026
US FDA• FORTEO
WLWarning Letter
Warning Letter Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. (Aug 6, 2026)
FDA issued a warning letter to Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 6, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
WLWarning Letter
Warning Letter Viva Raw LLC (Aug 5, 2026)
FDA issued a warning letter to Viva Raw LLC concerning Adulterated Animal Foods/Misbranded. Deterministic full-text screening identifies discussion of Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 5, 2026
US FDA• Adulterated Animal Foods/Misbranded
WLWarning Letter
Warning Letter Quantum Star LLC (Aug 5, 2026)
FDA issued a warning letter to Quantum Star LLC 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.
IssuedAug 5, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
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 MERCK SHARP DOHME (Aug 4, 2026)
FDA posted an approval letter for KEYTRUDA QLEX on 2026-08-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 4, 2026
US FDA• KEYTRUDA QLEX

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Approval Letter PRAGMA (Aug 6, 2026)

Approval Letter ALVOGEN (Aug 6, 2026)

Approval Letter ASCENDIS PHARMA BONE (Aug 6, 2026)

Approval Letter ALMAJECT (Aug 6, 2026)

Approval Letter AMGEN (Aug 6, 2026)

Approval Letter CELLTRION (Aug 6, 2026)

Approval Letter LILLY (Aug 6, 2026)

Warning Letter Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. (Aug 6, 2026)

Warning Letter Viva Raw LLC (Aug 5, 2026)

Warning Letter Quantum Star LLC (Aug 5, 2026)

Approval Letter BOEHRINGER INGELHEIM (Aug 4, 2026)

Approval Letter MERCK SHARP DOHME (Aug 4, 2026)