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 1417-1428 of 1819 letters

ALApproval Letter
Approval Letter PH HEALTH (Mar 24, 2026)
FDA posted an approval letter for KETALAR on 2026-03-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 016812 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 24, 2026
US FDA• KETALAR
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 23, 2026)
FDA posted an approval letter for OPUVIZ on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761350 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• OPUVIZ
ALApproval Letter
Approval Letter IMPAX (Mar 23, 2026)
FDA posted an approval letter for TWINJECT, ADRENACLICK on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020800 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• TWINJECT / ADRENACLICK
ALApproval Letter
Approval Letter IMPAX (Mar 23, 2026)
FDA posted an approval letter for CREXONT on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• CREXONT
ALApproval Letter
Approval Letter IMPAX (Mar 23, 2026)
FDA posted an approval letter for RYTARY on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203312 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• RYTARY
ALApproval Letter
Approval Letter ORGANON LLC (Mar 23, 2026)
FDA posted an approval letter for SINEMET CR on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019856 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• SINEMET CR
ALApproval Letter
Approval Letter ABBVIE (Mar 23, 2026)
FDA posted an approval letter for VYALEV on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216962 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• VYALEV
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 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 GLAXOSMITHKLINE LLC (Mar 23, 2026)
FDA posted an approval letter for MEPRON on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• MEPRON
ALApproval Letter
Approval Letter ANNORA PHARMA (Mar 23, 2026)
FDA posted an approval letter for DESOGESTREL AND ETHINYL ESTRADIOL on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219761 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• DESOGESTREL AND ETHINYL ESTRADIOL
ALApproval Letter
Approval Letter ABBVIE (Mar 23, 2026)
FDA posted an approval letter for DUOPA on 2026-03-23. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 203952 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 23, 2026
US FDA• DUOPA

Page 119 of 152

1…117 118 119 120 121…152

Approval Letter PH HEALTH (Mar 24, 2026)

Approval Letter SAMSUNG BIOEPIS CO LTD (Mar 23, 2026)

Approval Letter IMPAX (Mar 23, 2026)

Approval Letter IMPAX (Mar 23, 2026)

Approval Letter IMPAX (Mar 23, 2026)

Approval Letter ORGANON LLC (Mar 23, 2026)

Approval Letter ABBVIE (Mar 23, 2026)

Approval Letter ADIENNE SA (Mar 23, 2026)

Approval Letter ADIENNE SA (Mar 23, 2026)

Approval Letter GLAXOSMITHKLINE LLC (Mar 23, 2026)

Approval Letter ANNORA PHARMA (Mar 23, 2026)

Approval Letter ABBVIE (Mar 23, 2026)