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 1477-1488 of 1503 letters

ALApproval Letter
Approval Letter AMNEAL (Jan 13, 2026)
FDA issued an approval letter for IOHEXOL on 2026-01-13. The source metadata identifies ANDA 217737 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• IOHEXOL
ALApproval Letter
Approval Letter COSETTE PHARMS NC (Jan 13, 2026)
FDA issued an approval letter for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE on 2026-01-13. The source metadata identifies ANDA 218273 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
ALApproval Letter
Approval Letter AUROBINDO PHARMA LTD (Jan 13, 2026)
FDA issued an approval letter for PSEUDOEPHEDRINE HYDROCHLORIDE on 2026-01-13. The source metadata identifies ANDA 218854 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• PSEUDOEPHEDRINE HYDROCHLORIDE
ALApproval Letter
Approval Letter SANDOZ (Jan 13, 2026)
FDA issued an approval letter for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE on 2026-01-13. The source metadata identifies ANDA 202388 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ALApproval Letter
Approval Letter APOTEX (Jan 13, 2026)
FDA issued an approval letter for CLADRIBINE on 2026-01-13. The source metadata identifies ANDA 218425 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• CLADRIBINE
ALApproval Letter
Approval Letter NAVINTA LLC (Jan 13, 2026)
FDA issued an approval letter for DIAZEPAM on 2026-01-13. The source metadata identifies ANDA 217468 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• DIAZEPAM
ALApproval Letter
Approval Letter WATSON LABS INC (Jan 13, 2026)
FDA issued an approval letter for SITAGLIPTIN PHOSPHATE on 2026-01-13. The source metadata identifies ANDA 202327 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• SITAGLIPTIN PHOSPHATE
ALApproval Letter
Approval Letter MYLAN (Jan 13, 2026)
FDA issued an approval letter for LINAGLIPTIN on 2026-01-13. The source metadata identifies ANDA 208431 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• LINAGLIPTIN
ALApproval Letter
Approval Letter TEVA PHARMS USA INC (Jan 13, 2026)
FDA issued an approval letter for ESTRADIOL on 2026-01-13. The source metadata identifies ANDA 214137 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• ESTRADIOL
ALApproval Letter
Approval Letter AMNEAL IRELAND LTD (Jan 13, 2026)
FDA issued an approval letter for BECLOMETHASONE DIPROPIONATE on 2026-01-13. The source metadata identifies ANDA 213811 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• BECLOMETHASONE DIPROPIONATE
ALApproval Letter
Approval Letter APOTEX CORP (Jan 13, 2026)
FDA issued an approval letter for RIMEGEPANT on 2026-01-13. The source metadata identifies ANDA 219399 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• RIMEGEPANT
ALApproval Letter
Approval Letter SENTYNL THERAPS INC (Jan 13, 2026)
FDA issued an approval letter for ZYCUBO on 2026-01-13. The source metadata identifies NDA 211241 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 13, 2026
US FDA• ZYCUBO

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Approval Letter AMNEAL (Jan 13, 2026)

Approval Letter COSETTE PHARMS NC (Jan 13, 2026)

Approval Letter AUROBINDO PHARMA LTD (Jan 13, 2026)

Approval Letter SANDOZ (Jan 13, 2026)

Approval Letter APOTEX (Jan 13, 2026)

Approval Letter NAVINTA LLC (Jan 13, 2026)

Approval Letter WATSON LABS INC (Jan 13, 2026)

Approval Letter MYLAN (Jan 13, 2026)

Approval Letter TEVA PHARMS USA INC (Jan 13, 2026)

Approval Letter AMNEAL IRELAND LTD (Jan 13, 2026)

Approval Letter APOTEX CORP (Jan 13, 2026)

Approval Letter SENTYNL THERAPS INC (Jan 13, 2026)