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 481-492 of 1503 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 6, 2026)
FDA issued an approval letter for ZYRTEC ALLERGY on 2026-07-06. The source metadata identifies NDA 022578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• ZYRTEC ALLERGY
ALApproval Letter
Approval Letter NOVARTIS (Jul 6, 2026)
FDA issued an approval letter for KISQALI on 2026-07-06. The source metadata identifies NDA 209092 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• KISQALI
ALApproval Letter
Approval Letter SHIONOGI (Jul 6, 2026)
FDA issued an approval letter for FETROJA on 2026-07-06. The source metadata identifies NDA 209445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• FETROJA
ALApproval Letter
Approval Letter MICRO LABS (Jul 6, 2026)
FDA issued an approval letter for RIVAROXABAN on 2026-07-06. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• RIVAROXABAN
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 6, 2026)
FDA issued an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• ZYRTEC-D 12 HOUR
ALApproval Letter
Approval Letter MANKIND PHARMA (Jul 6, 2026)
FDA issued an approval letter for RIVAROXABAN on 2026-07-06. The source metadata identifies ANDA 220874 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• RIVAROXABAN
ALApproval Letter
Approval Letter NOVARTIS (Jul 6, 2026)
FDA issued an approval letter for KISQALI FEMARA CO-PACK (COPACKAGED) on 2026-07-06. The source metadata identifies NDA 209935 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 6, 2026
US FDA• KISQALI FEMARA CO-PACK (COPACKAGED)
ALApproval Letter
Approval Letter CELLTRION INC (Jul 2, 2026)
FDA issued an approval letter for TRUXIMA on 2026-07-02. The source metadata identifies BLA 761088 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• TRUXIMA
ALApproval Letter
Approval Letter MDD US (Jul 2, 2026)
FDA issued an approval letter for ONAPGO on 2026-07-02. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• ONAPGO
ALApproval Letter
Approval Letter VIVUS LLC (Jul 2, 2026)
FDA issued an approval letter for QSYMIA on 2026-07-02. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• QSYMIA
ALApproval Letter
Approval Letter INCYTE CORP (Jul 2, 2026)
FDA issued an approval letter for OPZELURA on 2026-07-02. The source metadata identifies NDA 215309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• OPZELURA
ALApproval Letter
Approval Letter LILLY (Jul 2, 2026)
FDA issued an approval letter for STRATTERA on 2026-07-02. The source metadata identifies NDA 021411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• STRATTERA

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Approval Letter KENVUE BRANDS (Jul 6, 2026)

Approval Letter NOVARTIS (Jul 6, 2026)

Approval Letter SHIONOGI (Jul 6, 2026)

Approval Letter MICRO LABS (Jul 6, 2026)

Approval Letter KENVUE BRANDS (Jul 6, 2026)

Approval Letter MANKIND PHARMA (Jul 6, 2026)

Approval Letter NOVARTIS (Jul 6, 2026)

Approval Letter CELLTRION INC (Jul 2, 2026)

Approval Letter MDD US (Jul 2, 2026)

Approval Letter VIVUS LLC (Jul 2, 2026)

Approval Letter INCYTE CORP (Jul 2, 2026)

Approval Letter LILLY (Jul 2, 2026)