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 1129-1140 of 1503 letters

ALApproval Letter
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)
FDA issued an approval letter for XTORO on 2026-03-20. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• XTORO
ALApproval Letter
Approval Letter HARROW EYE (Mar 20, 2026)
FDA issued an approval letter for IOPIDINE on 2026-03-20. The source metadata identifies NDA 019779 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• IOPIDINE
ALApproval Letter
Approval Letter PROVEPHARM SAS (Mar 20, 2026)
FDA issued an approval letter for BAL on 2026-03-20. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• BAL
ALApproval Letter
Approval Letter LUNDBECK PHARMS LLC (Mar 20, 2026)
FDA issued an approval letter for SABRIL on 2026-03-20. The source metadata identifies NDA 020427, NDA 022006 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• SABRIL
TATentative Approval Letter
Tentative Approval Letter APPCO PHARMA LLC (Mar 20, 2026)
FDA issued a tentative approval letter for ANDA 220327 on 2026-03-20. The source metadata identifies ANDA 220327 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• ANDA 220327
ALApproval Letter
Approval Letter HARROW EYE (Mar 20, 2026)
FDA issued an approval letter for IOPIDINE on 2026-03-20. The source metadata identifies NDA 020258 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• IOPIDINE
TATentative Approval Letter
Tentative Approval Letter APOTEX INC (Mar 20, 2026)
FDA issued a tentative approval letter for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE on 2026-03-20. The source metadata identifies ANDA 218575 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• ELVITEGRAVIR, COBICISTAT, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
ALApproval Letter
Approval Letter SOBI (Mar 20, 2026)
FDA issued an approval letter for VONJO on 2026-03-20. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• VONJO
ALApproval Letter
Approval Letter GENENTECH (Mar 20, 2026)
FDA issued an approval letter for POLIVY on 2026-03-20. The source metadata identifies BLA 761121 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• POLIVY
ALApproval Letter
Approval Letter NATCO PHARMA LTD (Mar 20, 2026)
FDA issued an approval letter for ERDAFITINIB on 2026-03-20. The source metadata identifies ANDA 218578 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• ERDAFITINIB
ALApproval Letter
Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)
FDA issued an approval letter for XTORO on 2026-03-20. The source metadata identifies NDA 206307 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• XTORO
ALApproval Letter
Approval Letter ORGANON (Mar 20, 2026)
FDA issued an approval letter for PROSCAR on 2026-03-20. The source metadata identifies NDA 020180 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 20, 2026
US FDA• PROSCAR

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Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)

Approval Letter HARROW EYE (Mar 20, 2026)

Approval Letter PROVEPHARM SAS (Mar 20, 2026)

Approval Letter LUNDBECK PHARMS LLC (Mar 20, 2026)

Tentative Approval Letter APPCO PHARMA LLC (Mar 20, 2026)

Approval Letter HARROW EYE (Mar 20, 2026)

Tentative Approval Letter APOTEX INC (Mar 20, 2026)

Approval Letter SOBI (Mar 20, 2026)

Approval Letter GENENTECH (Mar 20, 2026)

Approval Letter NATCO PHARMA LTD (Mar 20, 2026)

Approval Letter FONSECA BIOSCIENCES (Mar 20, 2026)

Approval Letter ORGANON (Mar 20, 2026)