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 409-420 of 1503 letters

TATentative Approval Letter
Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 22, 2026)
FDA issued a tentative approval letter for UBROGEPANT on 2026-07-22. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 22, 2026
US FDA• UBROGEPANT
TATentative Approval Letter
Tentative Approval Letter MSN LABORATORIES PRIVATE LIMITED (Jul 21, 2026)
FDA issued a tentative approval letter for UBROGEPANT on 2026-07-21. The source metadata identifies ANDA 219218 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• UBROGEPANT
TATentative Approval Letter
Tentative Approval Letter ALEMBIC PHARMACEUTICALS LIMITED (Jul 21, 2026)
FDA issued a tentative approval letter for LAROTRECTINIB on 2026-07-21. The source metadata identifies ANDA 220639 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• LAROTRECTINIB
TATentative Approval Letter
Tentative Approval Letter SANDOZ INC (Jul 21, 2026)
FDA issued a tentative approval letter for TIVOZANIB on 2026-07-21. The source metadata identifies ANDA 220437 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• TIVOZANIB
TATentative Approval Letter
Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026)
FDA issued a tentative approval letter for ANDA 220143 on 2026-07-21. The source metadata identifies ANDA 220143 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• ANDA 220143
TATentative Approval Letter
Tentative Approval Letter DEVA HOLDING AS (Jul 21, 2026)
FDA issued a tentative approval letter for CEFTRIAXONE on 2026-07-21. The source metadata identifies ANDA 210197 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• CEFTRIAXONE
TATentative Approval Letter
Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 21, 2026)
FDA issued a tentative approval letter for ANDA 220724 on 2026-07-21. The source metadata identifies ANDA 220724 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• ANDA 220724
TATentative Approval Letter
Tentative Approval Letter TEVA PHARMACEUTICALS, INC. (Jul 21, 2026)
FDA issued a tentative approval letter for ANDA 219413 on 2026-07-21. The source metadata identifies ANDA 219413 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• ANDA 219413
TATentative Approval Letter
Tentative Approval Letter SANDOZ INC (Jul 21, 2026)
FDA issued a tentative approval letter for PEMIGATINIB on 2026-07-21. The source metadata identifies ANDA 219552 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• PEMIGATINIB
ALApproval Letter
Approval Letter HIKMA (Jul 21, 2026)
FDA issued an approval letter for EPINEPHRINE on 2026-07-21. The source metadata identifies ANDA 220562 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• EPINEPHRINE
ALApproval Letter
Approval Letter OWP PHARMS (Jul 21, 2026)
FDA issued an approval letter for SUBVENITE on 2026-07-21. The source metadata identifies NDA 218879 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• SUBVENITE
ALApproval Letter
Approval Letter UMEDICA LABS PVT (Jul 21, 2026)
FDA issued an approval letter for ZOLPIDEM TARTRATE on 2026-07-21. The source metadata identifies ANDA 220717 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 21, 2026
US FDA• ZOLPIDEM TARTRATE

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Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 22, 2026)

Tentative Approval Letter MSN LABORATORIES PRIVATE LIMITED (Jul 21, 2026)

Tentative Approval Letter ALEMBIC PHARMACEUTICALS LIMITED (Jul 21, 2026)

Tentative Approval Letter SANDOZ INC (Jul 21, 2026)

Tentative Approval Letter HETERO LABS LIMITED (Jul 21, 2026)

Tentative Approval Letter DEVA HOLDING AS (Jul 21, 2026)

Tentative Approval Letter ZYDUS PHARMACEUTICALS (USA) INC. (Jul 21, 2026)

Tentative Approval Letter TEVA PHARMACEUTICALS, INC. (Jul 21, 2026)

Tentative Approval Letter SANDOZ INC (Jul 21, 2026)

Approval Letter HIKMA (Jul 21, 2026)

Approval Letter OWP PHARMS (Jul 21, 2026)

Approval Letter UMEDICA LABS PVT (Jul 21, 2026)