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 901-912 of 1503 letters

TATentative Approval Letter
Tentative Approval Letter ASPEN SA OPERATIONS (PTY) LTD (May 5, 2026)
FDA issued a tentative approval letter for DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE on 2026-05-05. The source metadata identifies NDA 219804 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 5, 2026
US FDA• DOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE
ALApproval Letter
Approval Letter OTSUKA (May 4, 2026)
FDA issued an approval letter for REXULTI on 2026-05-04. The source metadata identifies NDA 205422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• REXULTI
ALApproval Letter
Approval Letter JANSSEN BIOTECH (May 4, 2026)
FDA issued an approval letter for LAZCLUZE on 2026-05-04. The source metadata identifies NDA 219008 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• LAZCLUZE
ALApproval Letter
Approval Letter KRAMER (May 4, 2026)
FDA issued an approval letter for NIZORAL ANTI-DANDRUFF on 2026-05-04. The source metadata identifies NDA 020310 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• NIZORAL ANTI-DANDRUFF
ALApproval Letter
Approval Letter EXTROVIS (May 4, 2026)
FDA issued an approval letter for CARAC on 2026-05-04. The source metadata identifies NDA 020985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• CARAC
ALApproval Letter
Approval Letter HOSPIRA (May 4, 2026)
FDA issued an approval letter for PRECEDEX on 2026-05-04. The source metadata identifies NDA 021038 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• PRECEDEX
ALApproval Letter
Approval Letter RIGEL PHARMS (May 4, 2026)
FDA issued an approval letter for VEPPANU on 2026-05-04. The source metadata identifies NDA 219835 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• VEPPANU
ALApproval Letter
Approval Letter MAP77 (May 4, 2026)
FDA issued an approval letter for ATONCY on 2026-05-04. The source metadata identifies NDA 220320 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• ATONCY
ALApproval Letter
Approval Letter HOSPIRA (May 4, 2026)
FDA issued an approval letter for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-05-04. The source metadata identifies NDA 020201 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter INCYTE CORP (May 4, 2026)
FDA issued an approval letter for JAKAFI XR on 2026-05-04. The source metadata identifies NDA 217180 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• JAKAFI XR
ALApproval Letter
Approval Letter KARYOPHARM THERAPS (May 4, 2026)
FDA issued an approval letter for XPOVIO on 2026-05-04. The source metadata identifies NDA 212306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• XPOVIO
ALApproval Letter
Approval Letter HALEON US HOLDINGS (May 4, 2026)
FDA issued an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-05-04. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMay 4, 2026
US FDA• CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED

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Tentative Approval Letter ASPEN SA OPERATIONS (PTY) LTD (May 5, 2026)

Approval Letter OTSUKA (May 4, 2026)

Approval Letter JANSSEN BIOTECH (May 4, 2026)

Approval Letter KRAMER (May 4, 2026)

Approval Letter EXTROVIS (May 4, 2026)

Approval Letter HOSPIRA (May 4, 2026)

Approval Letter RIGEL PHARMS (May 4, 2026)

Approval Letter MAP77 (May 4, 2026)

Approval Letter HOSPIRA (May 4, 2026)

Approval Letter INCYTE CORP (May 4, 2026)

Approval Letter KARYOPHARM THERAPS (May 4, 2026)

Approval Letter HALEON US HOLDINGS (May 4, 2026)