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 1,503 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 385-396 of 1503 letters

ALApproval Letter
Approval Letter TEVA PHARMS USA (Jul 24, 2026)
FDA issued an approval letter for CANAGLIFLOZIN on 2026-07-24. The source metadata identifies ANDA 210451 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• CANAGLIFLOZIN
ALApproval Letter
Approval Letter KENVUE BRANDS LLC (Jul 24, 2026)
FDA issued an approval letter for TYLENOL WITH NAPROXEN on 2026-07-24. The source metadata identifies NDA 219962 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 24, 2026
US FDA• TYLENOL WITH NAPROXEN
ALApproval Letter
Approval Letter ACCORD (Jul 23, 2026)
FDA issued an approval letter for CAMCEVI ETM on 2026-07-23. The source metadata identifies NDA 219745 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 23, 2026
US FDA• CAMCEVI ETM
ALApproval Letter
Approval Letter BAUSCH (Jul 23, 2026)
FDA issued an approval letter for ACANYA, ONEXTON on 2026-07-23. The source metadata identifies NDA 050819 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 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)
ALApproval Letter
Approval Letter MYLAN (Jul 22, 2026)
FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 217769 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE
ALApproval Letter
Approval Letter INCYTE CORP (Jul 22, 2026)
FDA issued an approval letter for JAKAFI, JAKAFI XR on 2026-07-22. The source metadata identifies NDA 202192, NDA 217180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• JAKAFI / JAKAFI XR
TATentative Approval Letter
Tentative Approval Letter AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD (Jul 22, 2026)
FDA issued a tentative approval letter for ANDA 220197 on 2026-07-22. The source metadata identifies ANDA 220197 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• ANDA 220197
ALApproval Letter
Approval Letter HIKMA (Jul 22, 2026)
FDA issued an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 218016 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• SOLRIAMFETOL HYDROCHLORIDE
ALApproval Letter
Approval Letter ANNORA PHARMA (Jul 22, 2026)
FDA issued an approval letter for FOSTAMATINIB DISODIUM on 2026-07-22. The source metadata identifies ANDA 217329 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• FOSTAMATINIB DISODIUM
ALApproval Letter
Approval Letter LUPIN (Jul 22, 2026)
FDA issued an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
TATentative Approval Letter
Tentative Approval Letter MSN (Jul 22, 2026)
FDA issued a tentative approval letter for BOSUTINIB MONOHYDRATE, BOSUTINIB on 2026-07-22. The source metadata identifies ANDA 209624 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• BOSUTINIB MONOHYDRATE / BOSUTINIB

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Approval Letter TEVA PHARMS USA (Jul 24, 2026)

Approval Letter KENVUE BRANDS LLC (Jul 24, 2026)

Approval Letter ACCORD (Jul 23, 2026)

Approval Letter BAUSCH (Jul 23, 2026)

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

Approval Letter MYLAN (Jul 22, 2026)

Approval Letter INCYTE CORP (Jul 22, 2026)

Tentative Approval Letter AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD (Jul 22, 2026)

Approval Letter HIKMA (Jul 22, 2026)

Approval Letter ANNORA PHARMA (Jul 22, 2026)

Approval Letter LUPIN (Jul 22, 2026)

Tentative Approval Letter MSN (Jul 22, 2026)