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 661-672 of 1503 letters

ALApproval Letter
Approval Letter APOTEX (Jun 9, 2026)
FDA issued an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-06-09. The source metadata identifies ANDA 210273 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• MULTIPLE VITAMINS INJECTION ADULT
ALApproval Letter
Approval Letter BRISTOL MYERS SQUIBB (Jun 9, 2026)
FDA issued an approval letter for OPDUALAG on 2026-06-09. The source metadata identifies BLA 761234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• OPDUALAG
ALApproval Letter
Approval Letter PFIZER INC (Jun 9, 2026)
FDA issued an approval letter for HYMPAVZI on 2026-06-09. The source metadata identifies BLA 761369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• HYMPAVZI
ALApproval Letter
Approval Letter JAZZ PHARMS RES (Jun 9, 2026)
FDA issued an approval letter for EPIDIOLEX on 2026-06-09. The source metadata identifies NDA 210365 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• EPIDIOLEX
ALApproval Letter
Approval Letter ELI LILLY AND CO (Jun 9, 2026)
FDA issued an approval letter for EMGALITY on 2026-06-09. The source metadata identifies BLA 761063 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• EMGALITY
TATentative Approval Letter
Tentative Approval Letter NOVITIUM PHARMA (Jun 9, 2026)
FDA issued a tentative approval letter for PITOLISANT HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 218495 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• PITOLISANT HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter INVENTIA HEALTHCARE LIMITED (Jun 9, 2026)
FDA issued a tentative approval letter for ANDA 218760 on 2026-06-09. The source metadata identifies ANDA 218760 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• ANDA 218760
TATentative Approval Letter
Tentative Approval Letter ALKEM LABS LTD (Jun 9, 2026)
FDA issued a tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211563 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ALApproval Letter
Approval Letter CIPLA (Jun 9, 2026)
FDA issued an approval letter for NINTEDANIB ESYLATE on 2026-06-09. The source metadata identifies ANDA 212609 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• NINTEDANIB ESYLATE
ALApproval Letter
Approval Letter MYLAN (Jun 9, 2026)
FDA issued an approval letter for APREPITANT on 2026-06-09. The source metadata identifies ANDA 218851 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• APREPITANT
ALApproval Letter
Approval Letter CIPLA (Jun 9, 2026)
FDA issued an approval letter for ALBUTEROL SULFATE on 2026-06-09. The source metadata identifies ANDA 219409 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• ALBUTEROL SULFATE
ALApproval Letter
Approval Letter MSN (Jun 9, 2026)
FDA issued an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 9, 2026
US FDA• DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

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Approval Letter APOTEX (Jun 9, 2026)

Approval Letter BRISTOL MYERS SQUIBB (Jun 9, 2026)

Approval Letter PFIZER INC (Jun 9, 2026)

Approval Letter JAZZ PHARMS RES (Jun 9, 2026)

Approval Letter ELI LILLY AND CO (Jun 9, 2026)

Tentative Approval Letter NOVITIUM PHARMA (Jun 9, 2026)

Tentative Approval Letter INVENTIA HEALTHCARE LIMITED (Jun 9, 2026)

Tentative Approval Letter ALKEM LABS LTD (Jun 9, 2026)

Approval Letter CIPLA (Jun 9, 2026)

Approval Letter MYLAN (Jun 9, 2026)

Approval Letter CIPLA (Jun 9, 2026)

Approval Letter MSN (Jun 9, 2026)