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 589-600 of 1819 letters

ALApproval Letter
Approval Letter SUN PHARM INDS INC (Aug 14, 2026)
FDA posted an approval letter for ABSORICA, ABSORICA LD on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021951, NDA 211913 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• ABSORICA / ABSORICA LD
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Aug 14, 2026)
FDA posted an approval letter for KAZANO on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• KAZANO
ALApproval Letter
Approval Letter ASTRAZENECA AB (Aug 14, 2026)
FDA posted an approval letter for KOMBIGLYZE XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 200678 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• KOMBIGLYZE XR
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Aug 14, 2026)
FDA posted an approval letter for JENTADUETO, SYNJARDY, JENTADUETO XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201281, NDA 206111, NDA 208026, NDA 208658, NDA 212614 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• JENTADUETO / SYNJARDY / JENTADUETO XR
ALApproval Letter
Approval Letter ZYDUS LIFESCIENCES (Aug 14, 2026)
FDA posted an approval letter for ZITUVIMET, ZITUVIMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216743, NDA 216778 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• ZITUVIMET / ZITUVIMET XR
ALApproval Letter
Approval Letter ANDRX LABS LLC (Aug 14, 2026)
FDA posted an approval letter for FORTAMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021574 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• FORTAMET
ALApproval Letter
Approval Letter JANSSEN PHARMS (Aug 14, 2026)
FDA posted an approval letter for INVOKAMET, INVOKAMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204353, NDA 205879 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• INVOKAMET / INVOKAMET XR
ALApproval Letter
Approval Letter MSD SUB MERCK (Aug 14, 2026)
FDA posted an approval letter for JANUMET, JANUMET XR on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022044, NDA 202270 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• JANUMET / JANUMET XR
ALApproval Letter
Approval Letter MSD SUB MERCK (Aug 14, 2026)
FDA posted an approval letter for SEGLUROMET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209806 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• SEGLUROMET
ALApproval Letter
Approval Letter TAKEDA PHARMS USA (Aug 14, 2026)
FDA posted an approval letter for ACTOPLUS MET on 2026-08-14. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021842 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 14, 2026
US FDA• ACTOPLUS MET
WLWarning Letter
Warning Letter R3 Medical Companies (Aug 14, 2026)
FDA issued a warning letter to R3 Medical Companies concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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.
IssuedAug 14, 2026
US FDA• Unapproved New Drugs/Unlicensed Biological Product Violations
ALApproval Letter
Approval Letter SANDOZ (Aug 13, 2026)
FDA posted an approval letter for DUREZOL on 2026-08-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022212 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 13, 2026
US FDA• DUREZOL

Page 50 of 152

1…48 49 50 51 52…152

Approval Letter SUN PHARM INDS INC (Aug 14, 2026)

Approval Letter TAKEDA PHARMS USA (Aug 14, 2026)

Approval Letter ASTRAZENECA AB (Aug 14, 2026)

Approval Letter BOEHRINGER INGELHEIM (Aug 14, 2026)

Approval Letter ZYDUS LIFESCIENCES (Aug 14, 2026)

Approval Letter ANDRX LABS LLC (Aug 14, 2026)

Approval Letter JANSSEN PHARMS (Aug 14, 2026)

Approval Letter MSD SUB MERCK (Aug 14, 2026)

Approval Letter MSD SUB MERCK (Aug 14, 2026)

Approval Letter TAKEDA PHARMS USA (Aug 14, 2026)

Warning Letter R3 Medical Companies (Aug 14, 2026)

Approval Letter SANDOZ (Aug 13, 2026)