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 985-996 of 1819 letters

ALApproval Letter
Approval Letter MYLAN (Jun 9, 2026)
FDA posted an approval letter for APREPITANT on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• APREPITANT
ALApproval Letter
Approval Letter CIPLA (Jun 9, 2026)
FDA posted an approval letter for ALBUTEROL SULFATE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219409 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• ALBUTEROL SULFATE
ALApproval Letter
Approval Letter MSN (Jun 9, 2026)
FDA posted an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE
ALApproval Letter
Approval Letter SANDOZ (Jun 9, 2026)
FDA posted an approval letter for ENZALUTAMIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 216068 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• ENZALUTAMIDE
ALApproval Letter
Approval Letter AUROBINDO PHARMA LTD (Jun 9, 2026)
FDA posted an approval letter for CITALOPRAM HYDROBROMIDE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219985 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• CITALOPRAM HYDROBROMIDE
TATentative Approval Letter
Tentative Approval Letter TARO PHARMACEUTICALS INC (Jun 9, 2026)
FDA posted a tentative approval letter for ANDA 212211 on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212211 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• ANDA 212211
ALApproval Letter
Approval Letter ACCORD BIOPHARMA INC. (Jun 9, 2026)
FDA posted an approval letter for IMULDOSA on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761364 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• IMULDOSA
ALApproval Letter
Approval Letter Lundbeck Seattle BioPharmaceuticals, Inc. (Jun 9, 2026)
FDA posted an approval letter for VYEPTI on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761119 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• VYEPTI
ALApproval Letter
Approval Letter TEVA PHARMS USA (Jun 9, 2026)
FDA posted an approval letter for FERRIC CITRATE on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 212563 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• FERRIC CITRATE
ALApproval Letter
Approval Letter INVENTIA (Jun 9, 2026)
FDA posted an approval letter for DAPAGLIFLOZIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 9, 2026
US FDA• DAPAGLIFLOZIN
TATentative Approval Letter
Tentative Approval Letter APOTEX INC (Jun 8, 2026)
FDA posted a tentative approval letter for ANDA 220169 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220169 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• ANDA 220169
TATentative Approval Letter
Tentative Approval Letter ASCENT PHARMACEUTICALS INC. (Jun 8, 2026)
FDA posted a tentative approval letter for ANDA 220025 on 2026-06-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220025 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 8, 2026
US FDA• ANDA 220025

Page 83 of 152

1…81 82 83 84 85…152

Approval Letter MYLAN (Jun 9, 2026)

Approval Letter CIPLA (Jun 9, 2026)

Approval Letter MSN (Jun 9, 2026)

Approval Letter SANDOZ (Jun 9, 2026)

Approval Letter AUROBINDO PHARMA LTD (Jun 9, 2026)

Tentative Approval Letter TARO PHARMACEUTICALS INC (Jun 9, 2026)

Approval Letter ACCORD BIOPHARMA INC. (Jun 9, 2026)

Approval Letter Lundbeck Seattle BioPharmaceuticals, Inc. (Jun 9, 2026)

Approval Letter TEVA PHARMS USA (Jun 9, 2026)

Approval Letter INVENTIA (Jun 9, 2026)

Tentative Approval Letter APOTEX INC (Jun 8, 2026)

Tentative Approval Letter ASCENT PHARMACEUTICALS INC. (Jun 8, 2026)