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 1057-1068 of 1819 letters

ALApproval Letter
Approval Letter CYCLE (Jun 2, 2026)
FDA posted an approval letter for CAVHANZA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217379 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• CAVHANZA
ALApproval Letter
Approval Letter SHIONOGI (Jun 2, 2026)
FDA posted an approval letter for XOCOVA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220442 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• XOCOVA
ALApproval Letter
Approval Letter NOVO (Jun 2, 2026)
FDA posted an approval letter for OZEMPIC on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209637 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• OZEMPIC
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Jun 2, 2026)
FDA posted an approval letter for WELLCOVORIN on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018342 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• WELLCOVORIN
ALApproval Letter
Approval Letter NATCO (Jun 2, 2026)
FDA posted an approval letter for IDELALISIB on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216921 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• IDELALISIB
ALApproval Letter
Approval Letter TEVA PHARMS USA (Jun 2, 2026)
FDA posted an approval letter for AJOVY on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761089 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• AJOVY
ALApproval Letter
Approval Letter MERCK SHARP DOHME (Jun 2, 2026)
FDA posted an approval letter for KEYTRUDA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125514 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• KEYTRUDA
ALApproval Letter
Approval Letter ALEXION PHARM (Jun 2, 2026)
FDA posted an approval letter for SOLIRIS, ULTOMIRIS on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125166, BLA 761108 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• SOLIRIS / ULTOMIRIS
TATentative Approval Letter
Tentative Approval Letter LANTHEUS MEDICAL (Jun 2, 2026)
FDA posted a tentative approval letter for BRAVNETSA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217060 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• BRAVNETSA
TATentative Approval Letter
Tentative Approval Letter MACLEODS PHARMS (Jun 2, 2026)
FDA posted a tentative approval letter for MILNACIPRAN HYDROCHLORIDE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210944 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• MILNACIPRAN HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 2, 2026)
FDA posted a tentative approval letter for ANDA 217786 on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217786 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• ANDA 217786
TATentative Approval Letter
Tentative Approval Letter MANKIND PHARMA (Jun 2, 2026)
FDA posted a tentative approval letter for ANDA 212283 on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212283 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• ANDA 212283

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Approval Letter CYCLE (Jun 2, 2026)

Approval Letter SHIONOGI (Jun 2, 2026)

Approval Letter NOVO (Jun 2, 2026)

Approval Letter GLAXOSMITHKLINE (Jun 2, 2026)

Approval Letter NATCO (Jun 2, 2026)

Approval Letter TEVA PHARMS USA (Jun 2, 2026)

Approval Letter MERCK SHARP DOHME (Jun 2, 2026)

Approval Letter ALEXION PHARM (Jun 2, 2026)

Tentative Approval Letter LANTHEUS MEDICAL (Jun 2, 2026)

Tentative Approval Letter MACLEODS PHARMS (Jun 2, 2026)

Tentative Approval Letter AUROBINDO PHARMA LIMITED (Jun 2, 2026)

Tentative Approval Letter MANKIND PHARMA (Jun 2, 2026)