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 1429-1440 of 1819 letters

ALApproval Letter
Approval Letter DEPROCO (Mar 23, 2026)
FDA posted an approval letter for FLAVALTA on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216564 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• FLAVALTA
ALApproval Letter
Approval Letter ORGANON (Mar 23, 2026)
FDA posted an approval letter for SINEMET on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017555 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• SINEMET
ALApproval Letter
Approval Letter VIATRIS (Mar 23, 2026)
FDA posted an approval letter for EPIPEN, EPIPEN JR., EPIPEN E Z PEN on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019430 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• EPIPEN / EPIPEN JR. / EPIPEN E Z PEN
ALApproval Letter
Approval Letter AVION PHARMS (Mar 23, 2026)
FDA posted an approval letter for DHIVY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214869 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• DHIVY
TATentative Approval Letter
Tentative Approval Letter AMNEAL PHARMS NY (Mar 23, 2026)
FDA posted a tentative approval letter for KITPROZY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220712 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• KITPROZY
ALApproval Letter
Approval Letter ORION PHARMA (Mar 23, 2026)
FDA posted an approval letter for STALEVO 50, STALEVO 100, STALEVO 150 on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021485 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• STALEVO 50 / STALEVO 100 / STALEVO 150
ALApproval Letter
Approval Letter ADIENNE SA (Mar 23, 2026)
FDA posted an approval letter for TEPADINA, TEPADINA AND SODIUM CHLORIDE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208264 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• TEPADINA / TEPADINA AND SODIUM CHLORIDE
ALApproval Letter
Approval Letter RHYTHM (Mar 23, 2026)
FDA posted an approval letter for IMCIVREE on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213793 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• IMCIVREE
ALApproval Letter
Approval Letter NOVO (Mar 23, 2026)
FDA posted an approval letter for WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH on 2026-03-23. 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 FDAMar 23, 2026
US FDA• WEGOVY / WEGOVY HD / WEGOVY FLEXTOUCH
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Mar 23, 2026)
FDA posted an approval letter for OPDIVO on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125554 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• OPDIVO
WLWarning Letter
Warning Letter Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Mar 23, 2026)
FDA issued a warning letter to Xiamen Kang Zhongyuan Biotechnology Co., Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Data integrity and records, 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.
IssuedMar 23, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter GLENMARK SPECLT (Mar 20, 2026)
FDA posted an approval letter for FLUTICASONE PROPIONATE on 2026-03-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219602 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 20, 2026
US FDA• FLUTICASONE PROPIONATE

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Approval Letter DEPROCO (Mar 23, 2026)

Approval Letter ORGANON (Mar 23, 2026)

Approval Letter VIATRIS (Mar 23, 2026)

Approval Letter AVION PHARMS (Mar 23, 2026)

Tentative Approval Letter AMNEAL PHARMS NY (Mar 23, 2026)

Approval Letter ORION PHARMA (Mar 23, 2026)

Approval Letter ADIENNE SA (Mar 23, 2026)

Approval Letter RHYTHM (Mar 23, 2026)

Approval Letter NOVO (Mar 23, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Mar 23, 2026)

Warning Letter Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Mar 23, 2026)

Approval Letter GLENMARK SPECLT (Mar 20, 2026)