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 685-696 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter TEVA PHARMS USA (Jul 24, 2026)
FDA posted a tentative approval letter for CANAGLIFLOZIN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210451 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• CANAGLIFLOZIN
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 24, 2026)
FDA posted an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 24, 2026
US FDA• TYLENOL WITH NAPROXEN
WLWarning Letter
Warning Letter Nipro Renal Solutions USA, Corporation (Jul 24, 2026)
FDA issued a warning letter to Nipro Renal Solutions USA, Corporation concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Laboratory controls and testing, Labeling, claims, and misbranding, Medical device quality and reporting. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 24, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Dabur India Limited (Jul 24, 2026)
FDA issued a warning letter to Dabur India Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, 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.
IssuedJul 24, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Thomas Brunner Hygiene GmbH (Jul 24, 2026)
FDA issued a warning letter to Thomas Brunner Hygiene GmbH concerning CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, 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.
IssuedJul 24, 2026
US FDA• CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
WLWarning Letter
Warning Letter Wilson Livestock (Jul 24, 2026)
FDA issued a warning letter to Wilson Livestock concerning New Animal Drug/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.
IssuedJul 24, 2026
US FDA• New Animal Drug/Adulterated
ALApproval Letter
Approval Letter ACCORD (Jul 23, 2026)
FDA posted an approval letter for CAMCEVI ETM on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219745 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 23, 2026
US FDA• CAMCEVI ETM
ALApproval Letter
Approval Letter BAUSCH (Jul 23, 2026)
FDA posted an approval letter for ACANYA, ONEXTON on 2026-07-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 23, 2026
US FDA• ACANYA / ONEXTON
WLWarning Letter
Warning Letter Eherbs Imports, Inc (Jul 23, 2026)
FDA issued a warning letter to Eherbs Imports, Inc 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.
IssuedJul 23, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter ABS Corporation (Jul 23, 2026)
FDA issued a warning letter to ABS Corporation concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, 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.
IssuedJul 23, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter MYLAN (Jul 22, 2026)
FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217769 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE
ALApproval Letter
Approval Letter INCYTE CORP (Jul 22, 2026)
FDA posted an approval letter for JAKAFI, JAKAFI XR on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202192, NDA 217180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 22, 2026
US FDA• JAKAFI / JAKAFI XR

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Tentative Approval Letter TEVA PHARMS USA (Jul 24, 2026)

Approval Letter KENVUE BRANDS (Jul 24, 2026)

Warning Letter Nipro Renal Solutions USA, Corporation (Jul 24, 2026)

Warning Letter Dabur India Limited (Jul 24, 2026)

Warning Letter Thomas Brunner Hygiene GmbH (Jul 24, 2026)

Warning Letter Wilson Livestock (Jul 24, 2026)

Approval Letter ACCORD (Jul 23, 2026)

Approval Letter BAUSCH (Jul 23, 2026)

Warning Letter Eherbs Imports, Inc (Jul 23, 2026)

Warning Letter ABS Corporation (Jul 23, 2026)

Approval Letter MYLAN (Jul 22, 2026)

Approval Letter INCYTE CORP (Jul 22, 2026)