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 457-468 of 1819 letters

ALApproval Letter
Approval Letter ASTRAZENECA (Sep 15, 2026)
FDA posted an approval letter for TAGRISSO on 2026-09-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208065 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 15, 2026
US FDA• TAGRISSO
WLWarning Letter
Warning Letter Celmade (Sep 14, 2026)
FDA issued a warning letter to Celmade concerning Review of Website/Unapproved New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedSep 14, 2026
US FDA• Review of Website/Unapproved New Drug/Misbranded
ALApproval Letter
Approval Letter ASCEND THERAPS US (Sep 11, 2026)
FDA posted an approval letter for ESTROGEL on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021166 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 11, 2026
US FDA• ESTROGEL
ALApproval Letter
Approval Letter ZYDUS LIFESCIENCES (Sep 11, 2026)
FDA posted an approval letter for ZITUVIMET XR on 2026-09-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 11, 2026
US FDA• ZITUVIMET XR
WLWarning Letter
Warning Letter NexCell Scientific Inc (Sep 11, 2026)
FDA issued a warning letter to NexCell Scientific Inc concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, 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.
IssuedSep 11, 2026
US FDA• Unapproved New Drugs/Unlicensed Biological Product Violations
ALApproval Letter
Approval Letter ELI LILLY AND CO (Sep 10, 2026)
FDA posted an approval letter for ZEPBOUND (AUTOINJECTOR), ZEPBOUND, ZEPBOUND KWIKPEN on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 10, 2026
US FDA• ZEPBOUND (AUTOINJECTOR) / ZEPBOUND / ZEPBOUND KWIKPEN
ALApproval Letter
Approval Letter BIOFRONTERA (Sep 10, 2026)
FDA posted an approval letter for AMELUZ on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208081 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 10, 2026
US FDA• AMELUZ
ALApproval Letter
Approval Letter BAYER HEALTHCARE (Sep 10, 2026)
FDA posted an approval letter for HYRNUO on 2026-09-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219972 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 10, 2026
US FDA• HYRNUO
ALApproval Letter
Approval Letter ASTRAZENECA (Sep 8, 2026)
FDA posted an approval letter for ETCAMAH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220359 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 8, 2026
US FDA• ETCAMAH
ALApproval Letter
Approval Letter NOVO (Sep 8, 2026)
FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 8, 2026
US FDA• WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Sep 8, 2026)
FDA posted an approval letter for BYOOVIZ on 2026-09-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761202 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 8, 2026
US FDA• BYOOVIZ
ALApproval Letter
Approval Letter NOVO (Sep 8, 2026)
FDA posted an approval letter for OZEMPIC on 2026-09-08. 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 FDASep 8, 2026
US FDA• OZEMPIC

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Approval Letter ASTRAZENECA (Sep 15, 2026)

Warning Letter Celmade (Sep 14, 2026)

Approval Letter ASCEND THERAPS US (Sep 11, 2026)

Approval Letter ZYDUS LIFESCIENCES (Sep 11, 2026)

Warning Letter NexCell Scientific Inc (Sep 11, 2026)

Approval Letter ELI LILLY AND CO (Sep 10, 2026)

Approval Letter BIOFRONTERA (Sep 10, 2026)

Approval Letter BAYER HEALTHCARE (Sep 10, 2026)

Approval Letter ASTRAZENECA (Sep 8, 2026)

Approval Letter NOVO (Sep 8, 2026)

Approval Letter SAMSUNG BIOEPIS CO LTD (Sep 8, 2026)

Approval Letter NOVO (Sep 8, 2026)