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 1,819 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 793-804 of 1819 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 6, 2026)
FDA posted an approval letter for ZYRTEC ALLERGY on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022578 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• ZYRTEC ALLERGY
ALApproval Letter
Approval Letter NOVARTIS (Jul 6, 2026)
FDA posted an approval letter for KISQALI on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209092 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• KISQALI
ALApproval Letter
Approval Letter SHIONOGI (Jul 6, 2026)
FDA posted an approval letter for FETROJA on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209445 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• FETROJA
ALApproval Letter
Approval Letter MICRO LABS (Jul 6, 2026)
FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 208334 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• RIVAROXABAN
ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 6, 2026)
FDA posted an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• ZYRTEC-D 12 HOUR
ALApproval Letter
Approval Letter MANKIND PHARMA (Jul 6, 2026)
FDA posted an approval letter for RIVAROXABAN on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220874 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• RIVAROXABAN
ALApproval Letter
Approval Letter NOVARTIS (Jul 6, 2026)
FDA posted an approval letter for KISQALI FEMARA CO-PACK (COPACKAGED) on 2026-07-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209935 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 6, 2026
US FDA• KISQALI FEMARA CO-PACK (COPACKAGED)
WLWarning Letter
Warning Letter Waves and Wine, Inc. (Jul 6, 2026)
FDA issued a warning letter to Waves and Wine, Inc. concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 6, 2026
US FDA• CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
ALApproval Letter
Approval Letter CELLTRION INC (Jul 2, 2026)
FDA posted an approval letter for TRUXIMA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761088 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• TRUXIMA
ALApproval Letter
Approval Letter MDD US (Jul 2, 2026)
FDA posted an approval letter for ONAPGO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214056 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ONAPGO
ALApproval Letter
Approval Letter VIVUS LLC (Jul 2, 2026)
FDA posted an approval letter for QSYMIA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022580 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• QSYMIA
ALApproval Letter
Approval Letter INCYTE CORP (Jul 2, 2026)
FDA posted an approval letter for OPZELURA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215309 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• OPZELURA

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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)

Warning Letter Waves and Wine, Inc. (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)