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 1345-1356 of 1503 letters

ALApproval Letter
Approval Letter SANDOZ INC (Feb 12, 2026)
FDA issued an approval letter for ENZEEVU on 2026-02-12. The source metadata identifies BLA 761382 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 12, 2026
US FDA• ENZEEVU
WLWarning Letter
Warning Letter AQ USA Inc., d.b.a Ross Healthcare Inc. (Feb 12, 2026)
FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 12, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Black Sheep Egg Company, LLC (Feb 12, 2026)
FDA issued a warning letter to Black Sheep Egg Company, LLC concerning PHS Act/Shell Egg Regulation/Adulterated. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedFeb 12, 2026
US FDA• PHS Act/Shell Egg Regulation/Adulterated
WLWarning Letter
Warning Letter A. Nelson & Co. Ltd. (Feb 12, 2026)
FDA issued a warning letter to A. Nelson & Co. Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedFeb 12, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
TATentative Approval Letter
Tentative Approval Letter RUBICON RESEARCH PRIVATE LIMITED (Feb 11, 2026)
FDA issued a tentative approval letter for ANDA 219440 on 2026-02-11. The source metadata identifies ANDA 219440 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• ANDA 219440
ALApproval Letter
Approval Letter ALKEM LABS LTD (Feb 11, 2026)
FDA issued an approval letter for MIRABEGRON on 2026-02-11. The source metadata identifies ANDA 219323 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• MIRABEGRON
ALApproval Letter
Approval Letter EPIC PHARMA LLC (Feb 11, 2026)
FDA issued an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. The source metadata identifies ANDA 214378 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• TAPENTADOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter AUROBINDO PHARMA (Feb 11, 2026)
FDA issued a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• GLYCEROL PHENYLBUTYRATE
ALApproval Letter
Approval Letter GLAND (Feb 11, 2026)
FDA issued an approval letter for BORTEZOMIB on 2026-02-11. The source metadata identifies ANDA 219167 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• BORTEZOMIB
TATentative Approval Letter
Tentative Approval Letter MYLAN PHARMACEUTICALS INC (Feb 11, 2026)
FDA issued a tentative approval letter for RIFAXIMIN on 2026-02-11. The source metadata identifies ANDA 219687 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• RIFAXIMIN
ALApproval Letter
Approval Letter NOVAST LABS (Feb 11, 2026)
FDA issued an approval letter for CONJUGATED ESTROGENS on 2026-02-11. The source metadata identifies ANDA 214025 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• CONJUGATED ESTROGENS
ALApproval Letter
Approval Letter NOVAST LABS (Feb 11, 2026)
FDA issued an approval letter for CONJUGATED ESTROGENS on 2026-02-11. The source metadata identifies ANDA 214023 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedFeb 11, 2026
US FDA• CONJUGATED ESTROGENS

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Approval Letter SANDOZ INC (Feb 12, 2026)

Warning Letter AQ USA Inc., d.b.a Ross Healthcare Inc. (Feb 12, 2026)

Warning Letter Black Sheep Egg Company, LLC (Feb 12, 2026)

Warning Letter A. Nelson & Co. Ltd. (Feb 12, 2026)

Tentative Approval Letter RUBICON RESEARCH PRIVATE LIMITED (Feb 11, 2026)

Approval Letter ALKEM LABS LTD (Feb 11, 2026)

Approval Letter EPIC PHARMA LLC (Feb 11, 2026)

Tentative Approval Letter AUROBINDO PHARMA (Feb 11, 2026)

Approval Letter GLAND (Feb 11, 2026)

Tentative Approval Letter MYLAN PHARMACEUTICALS INC (Feb 11, 2026)

Approval Letter NOVAST LABS (Feb 11, 2026)

Approval Letter NOVAST LABS (Feb 11, 2026)