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 397-408 of 1503 letters

ALApproval Letter
Approval Letter SANDOZ (Jul 22, 2026)
FDA issued an approval letter for VASOPRESSIN on 2026-07-22. The source metadata identifies ANDA 212069 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• VASOPRESSIN
ALApproval Letter
Approval Letter AMNEAL (Jul 22, 2026)
FDA issued an approval letter for ROMIDEPSIN on 2026-07-22. The source metadata identifies ANDA 219099 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• ROMIDEPSIN
ALApproval Letter
Approval Letter PAI HOLDINGS (Jul 22, 2026)
FDA issued an approval letter for PROPRANOLOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 219165 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• PROPRANOLOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter AFT PHARMACEUTICALS LTD (Jul 22, 2026)
FDA issued a tentative approval letter for SCOMARA on 2026-07-22. The source metadata identifies NDA 218528 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• SCOMARA
ALApproval Letter
Approval Letter BRISTOL-MYERS (Jul 22, 2026)
FDA issued an approval letter for INREBIC on 2026-07-22. The source metadata identifies NDA 212327 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• INREBIC
ALApproval Letter
Approval Letter SOBI (Jul 22, 2026)
FDA issued an approval letter for VONJO on 2026-07-22. The source metadata identifies NDA 208712 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• VONJO
ALApproval Letter
Approval Letter MYLAN (Jul 22, 2026)
FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 217076 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE
TATentative Approval Letter
Tentative Approval Letter APOTEX INC (Jul 22, 2026)
FDA issued a tentative approval letter for RUXOLITINIB on 2026-07-22. The source metadata identifies ANDA 208869 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• RUXOLITINIB
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Jul 22, 2026)
FDA issued an approval letter for OJJAARA on 2026-07-22. The source metadata identifies NDA 216873 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• OJJAARA
ALApproval Letter
Approval Letter MYLAN LABS LTD (Jul 22, 2026)
FDA issued an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. The source metadata identifies ANDA 212572 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• FERRIC CARBOXYMALTOSE
ALApproval Letter
Approval Letter DR REDDYS (Jul 22, 2026)
FDA issued an approval letter for VENETOCLAX on 2026-07-22. The source metadata identifies ANDA 214733 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• VENETOCLAX
ALApproval Letter
Approval Letter ALKEM LABS LTD (Jul 22, 2026)
FDA issued an approval letter for SOLRIAMFETOL HYDROCHLORIDE on 2026-07-22. The source metadata identifies ANDA 218722 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• SOLRIAMFETOL HYDROCHLORIDE

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Approval Letter SANDOZ (Jul 22, 2026)

Approval Letter AMNEAL (Jul 22, 2026)

Approval Letter PAI HOLDINGS (Jul 22, 2026)

Tentative Approval Letter AFT PHARMACEUTICALS LTD (Jul 22, 2026)

Approval Letter BRISTOL-MYERS (Jul 22, 2026)

Approval Letter SOBI (Jul 22, 2026)

Approval Letter MYLAN (Jul 22, 2026)

Tentative Approval Letter APOTEX INC (Jul 22, 2026)

Approval Letter GLAXOSMITHKLINE (Jul 22, 2026)

Approval Letter MYLAN LABS LTD (Jul 22, 2026)

Approval Letter DR REDDYS (Jul 22, 2026)

Approval Letter ALKEM LABS LTD (Jul 22, 2026)