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 1,503 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 1503 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Jul 20, 2026)
FDA issued an approval letter for CHILDREN'S ZYRTEC HIVES, CHILDREN'S ZYRTEC ALLERGY on 2026-07-20. The source metadata identifies NDA 022155 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• CHILDREN'S ZYRTEC HIVES / CHILDREN'S ZYRTEC ALLERGY
ALApproval Letter
Approval Letter AMGEN (Jul 20, 2026)
FDA issued an approval letter for NEUPOGEN on 2026-07-20. The source metadata identifies BLA 103353 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• NEUPOGEN
ALApproval Letter
Approval Letter NOVARTIS (Jul 20, 2026)
FDA issued an approval letter for GLEEVEC on 2026-07-20. The source metadata identifies NDA 021588 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• GLEEVEC
ALApproval Letter
Approval Letter SUN PHARMA GLOBAL (Jul 20, 2026)
FDA issued an approval letter for ILUMYA on 2026-07-20. The source metadata identifies BLA 761067 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• ILUMYA
ALApproval Letter
Approval Letter RENEW PHARMS (Jul 20, 2026)
FDA issued an approval letter for IC-GREEN on 2026-07-20. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• IC-GREEN
ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050710, NDA 050784, NDA 050711 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter PFIZER (Jul 20, 2026)
FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050733 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• ZITHROMAX
ALApproval Letter
Approval Letter NOVA LABS LTD (Jul 20, 2026)
FDA issued an approval letter for PURIXAN on 2026-07-20. The source metadata identifies NDA 205919 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• PURIXAN
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jul 20, 2026)
FDA issued an approval letter for VERZENIO on 2026-07-20. The source metadata identifies NDA 208716 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• VERZENIO
ALApproval Letter
Approval Letter MUNDIPHARMA (Jul 20, 2026)
FDA issued an approval letter for REZZAYO on 2026-07-20. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• REZZAYO
ALApproval Letter
Approval Letter MEDUNIK (Jul 20, 2026)
FDA issued an approval letter for PHEBURANE on 2026-07-20. The source metadata identifies NDA 216513 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJul 20, 2026
US FDA• PHEBURANE

Page 37 of 126

1…35 36 37 38 39…126

Approval Letter KENVUE BRANDS (Jul 20, 2026)

Approval Letter AMGEN (Jul 20, 2026)

Approval Letter NOVARTIS (Jul 20, 2026)

Approval Letter SUN PHARMA GLOBAL (Jul 20, 2026)

Approval Letter RENEW PHARMS (Jul 20, 2026)

Approval Letter PFIZER (Jul 20, 2026)

Approval Letter PFIZER (Jul 20, 2026)

Approval Letter PFIZER (Jul 20, 2026)

Approval Letter NOVA LABS LTD (Jul 20, 2026)

Approval Letter ELI LILLY AND CO (Jul 20, 2026)

Approval Letter MUNDIPHARMA (Jul 20, 2026)

Approval Letter MEDUNIK (Jul 20, 2026)