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 733-744 of 1819 letters

ALApproval Letter
Approval Letter SPRINGWORKS (Jul 21, 2026)
FDA posted an approval letter for OGSIVEO on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• OGSIVEO
TATentative Approval Letter
Tentative Approval Letter AZURITY PHARMACEUTICALS INC (Jul 21, 2026)
FDA posted a tentative approval letter for EDARAVONE on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 221059 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 21, 2026
US FDA• EDARAVONE
WLWarning Letter
Warning Letter Koven Technologies, Inc. (Jul 21, 2026)
FDA issued a warning letter to Koven Technologies, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Quality systems and CAPA, Manufacturing and CGMP controls, 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 21, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter EISAI INC (Jul 20, 2026)
FDA posted an approval letter for LEQEMBI IQLIK on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761375 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• LEQEMBI IQLIK
ALApproval Letter
Approval Letter NOVARTIS (Jul 20, 2026)
FDA posted an approval letter for FABHALTA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218276 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• FABHALTA
ALApproval Letter
Approval Letter RUBICON RESEARCH (Jul 20, 2026)
FDA posted an approval letter for BUPRENORPHINE HYDROCHLORIDE on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 090279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• BUPRENORPHINE HYDROCHLORIDE
ALApproval Letter
Approval Letter FRESENIUS KABI USA (Jul 20, 2026)
FDA posted an approval letter for ARGATROBAN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201811 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• ARGATROBAN
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 20, 2026)
FDA posted an approval letter for CHILDREN'S ZYRTEC HIVES, CHILDREN'S ZYRTEC ALLERGY on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• CHILDREN'S ZYRTEC HIVES / CHILDREN'S ZYRTEC ALLERGY
ALApproval Letter
Approval Letter AMGEN (Jul 20, 2026)
FDA posted an approval letter for NEUPOGEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 103353 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• NEUPOGEN
ALApproval Letter
Approval Letter NOVARTIS (Jul 20, 2026)
FDA posted an approval letter for GLEEVEC on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• GLEEVEC
ALApproval Letter
Approval Letter SUN PHARMA GLOBAL (Jul 20, 2026)
FDA posted an approval letter for ILUMYA on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761067 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• ILUMYA
ALApproval Letter
Approval Letter RENEW PHARMS (Jul 20, 2026)
FDA posted an approval letter for IC-GREEN on 2026-07-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 20, 2026
US FDA• IC-GREEN

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Approval Letter SPRINGWORKS (Jul 21, 2026)

Tentative Approval Letter AZURITY PHARMACEUTICALS INC (Jul 21, 2026)

Warning Letter Koven Technologies, Inc. (Jul 21, 2026)

Approval Letter EISAI INC (Jul 20, 2026)

Approval Letter NOVARTIS (Jul 20, 2026)

Approval Letter RUBICON RESEARCH (Jul 20, 2026)

Approval Letter FRESENIUS KABI USA (Jul 20, 2026)

Approval Letter KENVUE BRANDS (Jul 20, 2026)

Approval Letter AMGEN (Jul 20, 2026)

Approval Letter NOVARTIS (Jul 20, 2026)

Approval Letter SUN PHARMA GLOBAL (Jul 20, 2026)

Approval Letter RENEW PHARMS (Jul 20, 2026)