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 817-828 of 1819 letters

ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Jul 2, 2026)
FDA posted an approval letter for EPYSQLI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• EPYSQLI
ALApproval Letter
Approval Letter PFIZER (Jul 2, 2026)
FDA posted an approval letter for CIBINQO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213871 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• CIBINQO
ALApproval Letter
Approval Letter AMGEN INC (Jul 2, 2026)
FDA posted an approval letter for BKEMV on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761333 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• BKEMV
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jul 2, 2026)
FDA posted an approval letter for OLUMIANT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207924 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• OLUMIANT
ALApproval Letter
Approval Letter SUN PHARM INDS INC (Jul 2, 2026)
FDA posted an approval letter for LEQSELVI on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• LEQSELVI
ALApproval Letter
Approval Letter ABBVIE (Jul 2, 2026)
FDA posted an approval letter for RINVOQ, RINVOQ LQ on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211675, NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• RINVOQ / RINVOQ LQ
ALApproval Letter
Approval Letter ESJAY PHARMA (Jul 2, 2026)
FDA posted an approval letter for PARLODEL on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• PARLODEL
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Jul 2, 2026)
FDA posted an approval letter for ERLEADA on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ERLEADA
ALApproval Letter
Approval Letter ARCUTIS (Jul 2, 2026)
FDA posted an approval letter for ZORYVE on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• ZORYVE
ALApproval Letter
Approval Letter PFIZER (Jul 2, 2026)
FDA posted an approval letter for LITFULO on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215830 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 2, 2026
US FDA• LITFULO
ALApproval Letter
Approval Letter CYCLE (Jul 2, 2026)
FDA posted an approval letter for TASCENSO ODT on 2026-07-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 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 full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, 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 2, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

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Approval Letter SAMSUNG BIOEPIS CO LTD (Jul 2, 2026)

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)