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 505-516 of 1503 letters

ALApproval Letter
Approval Letter PFIZER (Jul 2, 2026)
FDA issued an approval letter for CIBINQO on 2026-07-02. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• CIBINQO
ALApproval Letter
Approval Letter AMGEN INC (Jul 2, 2026)
FDA issued an approval letter for BKEMV on 2026-07-02. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• BKEMV
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jul 2, 2026)
FDA issued an approval letter for OLUMIANT on 2026-07-02. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• OLUMIANT
ALApproval Letter
Approval Letter SUN PHARM INDS INC (Jul 2, 2026)
FDA issued an approval letter for LEQSELVI on 2026-07-02. The source metadata identifies NDA 217900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• LEQSELVI
ALApproval Letter
Approval Letter ABBVIE (Jul 2, 2026)
FDA issued an approval letter for RINVOQ, RINVOQ LQ on 2026-07-02. The source metadata identifies NDA 211675, NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• RINVOQ / RINVOQ LQ
ALApproval Letter
Approval Letter ESJAY PHARMA (Jul 2, 2026)
FDA issued an approval letter for PARLODEL on 2026-07-02. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• PARLODEL
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Jul 2, 2026)
FDA issued an approval letter for ERLEADA on 2026-07-02. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• ERLEADA
ALApproval Letter
Approval Letter ARCUTIS (Jul 2, 2026)
FDA issued an approval letter for ZORYVE on 2026-07-02. The source metadata identifies NDA 215985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• ZORYVE
ALApproval Letter
Approval Letter PFIZER (Jul 2, 2026)
FDA issued an approval letter for LITFULO on 2026-07-02. The source metadata identifies NDA 215830 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• LITFULO
ALApproval Letter
Approval Letter CYCLE (Jul 2, 2026)
FDA issued an approval letter for TASCENSO ODT on 2026-07-02. The source metadata identifies NDA 214962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 2, 2026
US FDA• TASCENSO ODT
WLWarning Letter
Warning Letter International Medication Systems Limited (Jul 2, 2026)
FDA issued a warning letter to International Medication Systems Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 2, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter eliquidflavourconcentrates.co.uk (Jul 2, 2026)
FDA issued a warning letter to eliquidflavourconcentrates.co.uk concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedJul 2, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Page 43 of 126

1…41 42 43 44 45…126

Approval Letter PFIZER (Jul 2, 2026)

Approval Letter AMGEN INC (Jul 2, 2026)

Approval Letter ELI LILLY AND CO (Jul 2, 2026)

Approval Letter SUN PHARM INDS INC (Jul 2, 2026)

Approval Letter ABBVIE (Jul 2, 2026)

Approval Letter ESJAY PHARMA (Jul 2, 2026)

Approval Letter JANSSEN BIOTECH (Jul 2, 2026)

Approval Letter ARCUTIS (Jul 2, 2026)

Approval Letter PFIZER (Jul 2, 2026)

Approval Letter CYCLE (Jul 2, 2026)

Warning Letter International Medication Systems Limited (Jul 2, 2026)

Warning Letter eliquidflavourconcentrates.co.uk (Jul 2, 2026)