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 1717-1728 of 1819 letters

ALApproval Letter
Approval Letter GENSCO (Jan 30, 2026)
FDA posted an approval letter for RIZAFILM on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 30, 2026
US FDA• RIZAFILM
ALApproval Letter
Approval Letter PFIZER (Jan 30, 2026)
FDA posted an approval letter for LORBRENA on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210868 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 30, 2026
US FDA• LORBRENA
ALApproval Letter
Approval Letter NOVO (Jan 30, 2026)
FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215256, NDA 218316 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 30, 2026
US FDA• WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
ALApproval Letter
Approval Letter JOURNEY (Jan 30, 2026)
FDA posted an approval letter for XIMINO on 2026-01-30. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 201922 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 30, 2026
US FDA• XIMINO
WLWarning Letter
Warning Letter gotpouches.com (Jan 30, 2026)
FDA issued a warning letter to gotpouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, 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.
IssuedJan 30, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Cohance Lifesciences Limited (Jan 30, 2026)
FDA issued a warning letter to Cohance Lifesciences Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 30, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter niqpouches.com (Jan 30, 2026)
FDA issued a warning letter to niqpouches.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, Unapproved products and premarket authorization, 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.
IssuedJan 30, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter OTSUKA PHARM CO LTD (Jan 29, 2026)
FDA posted an approval letter for ABILIFY MAINTENA KIT on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 202971 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 29, 2026
US FDA• ABILIFY MAINTENA KIT
ALApproval Letter
Approval Letter PF PRISM CV (Jan 29, 2026)
FDA posted an approval letter for VFEND on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021266, NDA 021267, NDA 021630 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 29, 2026
US FDA• VFEND
ALApproval Letter
Approval Letter VISUS (Jan 29, 2026)
FDA posted an approval letter for YUVEZZI on 2026-01-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220142 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 29, 2026
US FDA• YUVEZZI
WLWarning Letter
Warning Letter Central Coast Multispecialty Medical Group, Inc. (Jan 29, 2026)
FDA issued a warning letter to Central Coast Multispecialty Medical Group, Inc. concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Deterministic full-text screening identifies discussion of 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.
IssuedJan 29, 2026
US FDA• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
WLWarning Letter
Warning Letter Fidelity Melon, Inc (Jan 29, 2026)
FDA issued a warning letter to Fidelity Melon, Inc concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJan 29, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

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Approval Letter GENSCO (Jan 30, 2026)

Approval Letter PFIZER (Jan 30, 2026)

Approval Letter NOVO (Jan 30, 2026)

Approval Letter JOURNEY (Jan 30, 2026)

Warning Letter gotpouches.com (Jan 30, 2026)

Warning Letter Cohance Lifesciences Limited (Jan 30, 2026)

Warning Letter niqpouches.com (Jan 30, 2026)

Approval Letter OTSUKA PHARM CO LTD (Jan 29, 2026)

Approval Letter PF PRISM CV (Jan 29, 2026)

Approval Letter VISUS (Jan 29, 2026)

Warning Letter Central Coast Multispecialty Medical Group, Inc. (Jan 29, 2026)

Warning Letter Fidelity Melon, Inc (Jan 29, 2026)