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 661-672 of 1819 letters

ALApproval Letter
Approval Letter VANDA PHARMS INC (Jul 29, 2026)
FDA posted an approval letter for HETLIOZ on 2026-07-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 29, 2026
US FDA• HETLIOZ
ALApproval Letter
Approval Letter SANOFI AVENTIS US (Jul 28, 2026)
FDA posted an approval letter for AVAPRO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020757 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• AVAPRO
ALApproval Letter
Approval Letter EMERGE BIOSCIENCE PTE. LTD. (Jul 28, 2026)
FDA posted an approval letter for GARZULYS on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761497 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• GARZULYS
ALApproval Letter
Approval Letter OUTLOOK THERAPEUTICS, INC. (Jul 28, 2026)
FDA posted an approval letter for LYTENAVA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761320 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• LYTENAVA
ALApproval Letter
Approval Letter XTTRIUM (Jul 28, 2026)
FDA posted an approval letter for DYNA-HEX 2 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019422 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• DYNA-HEX 2
ALApproval Letter
Approval Letter XTTRIUM (Jul 28, 2026)
FDA posted an approval letter for DYNA-HEX 4 on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019125 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• DYNA-HEX 4
ALApproval Letter
Approval Letter MADRIGAL (Jul 28, 2026)
FDA posted an approval letter for REZDIFFRA on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217785 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• REZDIFFRA
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Jul 28, 2026)
FDA posted an approval letter for BREXAFEMME on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214900 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• BREXAFEMME
ALApproval Letter
Approval Letter OTSUKA PHARMACEUTICAL CO LTD (Jul 28, 2026)
FDA posted an approval letter for SIMTRIYO on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218145 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• SIMTRIYO
ALApproval Letter
Approval Letter MERIDIAN BIOSCIENCE (Jul 28, 2026)
FDA posted an approval letter for IDKIT:HP on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021314 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• IDKIT:HP
ALApproval Letter
Approval Letter TEVA BRANDED PHARM (Jul 28, 2026)
FDA posted an approval letter for ZIAC on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• ZIAC
ALApproval Letter
Approval Letter ASTELLAS (Jul 28, 2026)
FDA posted an approval letter for XTANDI on 2026-07-28. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203415, NDA 213674 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJul 28, 2026
US FDA• XTANDI

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Approval Letter VANDA PHARMS INC (Jul 29, 2026)

Approval Letter SANOFI AVENTIS US (Jul 28, 2026)

Approval Letter EMERGE BIOSCIENCE PTE. LTD. (Jul 28, 2026)

Approval Letter OUTLOOK THERAPEUTICS, INC. (Jul 28, 2026)

Approval Letter XTTRIUM (Jul 28, 2026)

Approval Letter XTTRIUM (Jul 28, 2026)

Approval Letter MADRIGAL (Jul 28, 2026)

Approval Letter GLAXOSMITHKLINE (Jul 28, 2026)

Approval Letter OTSUKA PHARMACEUTICAL CO LTD (Jul 28, 2026)

Approval Letter MERIDIAN BIOSCIENCE (Jul 28, 2026)

Approval Letter TEVA BRANDED PHARM (Jul 28, 2026)

Approval Letter ASTELLAS (Jul 28, 2026)