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 433-444 of 1819 letters

ALApproval Letter
Approval Letter MAYNE PHARMA (Sep 22, 2026)
FDA posted an approval letter for ANNOVERA on 2026-09-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 22, 2026
US FDA• ANNOVERA
WLWarning Letter
Warning Letter Fresenius Kabi USA LLC (Sep 22, 2026)
FDA issued a warning letter to Fresenius Kabi USA LLC 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.
IssuedSep 22, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Unilam Co., LTD (Sep 22, 2026)
FDA issued a warning letter to Unilam Co., LTD concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Medical device quality and reporting, Quality systems and CAPA, Labeling, claims, and misbranding, 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.
IssuedSep 22, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter JANSSEN PHARMS (Sep 21, 2026)
FDA posted an approval letter for SPRAVATO on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• SPRAVATO
ALApproval Letter
Approval Letter NUVATION (Sep 21, 2026)
FDA posted an approval letter for IBTROZI on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219713 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• IBTROZI
ALApproval Letter
Approval Letter BAYER HEALTHCARE (Sep 21, 2026)
FDA posted an approval letter for AMBELVIST on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219627 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• AMBELVIST
ALApproval Letter
Approval Letter RIDHISIDHI, PLLC (Sep 21, 2026)
FDA posted an approval letter for EMPAGLIFLOZIN on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220758 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• EMPAGLIFLOZIN
ALApproval Letter
Approval Letter PF PRISM CV (Sep 21, 2026)
FDA posted an approval letter for XELJANZ, XELJANZ XR on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203214, NDA 208246, NDA 213082 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• XELJANZ / XELJANZ XR
ALApproval Letter
Approval Letter ASTRAZENECA (Sep 21, 2026)
FDA posted an approval letter for TRUQAP on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• TRUQAP
ALApproval Letter
Approval Letter NOVARTIS (Sep 21, 2026)
FDA posted an approval letter for ZORTRESS on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021560 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• ZORTRESS
ALApproval Letter
Approval Letter BAYER HLTHCARE (Sep 21, 2026)
FDA posted an approval letter for KERENDIA on 2026-09-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215341 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDASep 21, 2026
US FDA• KERENDIA
WLWarning Letter
Warning Letter Babikian Healthcare Products CJSC (Sep 21, 2026)
FDA issued a warning letter to Babikian Healthcare Products CJSC concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, 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.
IssuedSep 21, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

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Approval Letter MAYNE PHARMA (Sep 22, 2026)

Warning Letter Fresenius Kabi USA LLC (Sep 22, 2026)

Warning Letter Unilam Co., LTD (Sep 22, 2026)

Approval Letter JANSSEN PHARMS (Sep 21, 2026)

Approval Letter NUVATION (Sep 21, 2026)

Approval Letter BAYER HEALTHCARE (Sep 21, 2026)

Approval Letter RIDHISIDHI, PLLC (Sep 21, 2026)

Approval Letter PF PRISM CV (Sep 21, 2026)

Approval Letter ASTRAZENECA (Sep 21, 2026)

Approval Letter NOVARTIS (Sep 21, 2026)

Approval Letter BAYER HLTHCARE (Sep 21, 2026)

Warning Letter Babikian Healthcare Products CJSC (Sep 21, 2026)