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 1657-1668 of 1819 letters

ALApproval Letter
Approval Letter ASPEN (Feb 12, 2026)
FDA posted an approval letter for ENJUVIA on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021443 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• ENJUVIA
ALApproval Letter
Approval Letter PFIZER (Feb 12, 2026)
FDA posted an approval letter for PAXLOVID (COPACKAGED) on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217188 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• PAXLOVID (COPACKAGED)
ALApproval Letter
Approval Letter EMERGENT (Feb 12, 2026)
FDA posted an approval letter for NARCAN on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208411 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• NARCAN
ALApproval Letter
Approval Letter PFIZER (Feb 12, 2026)
FDA posted an approval letter for ESTRING on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 12, 2026
US FDA• ESTRING
ALApproval Letter
Approval Letter SANDOZ INC (Feb 12, 2026)
FDA posted an approval letter for ENZEEVU on 2026-02-12. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761382 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 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 full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, Labeling, claims, and misbranding. 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 posted a tentative approval letter for ANDA 219440 on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219440 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• ANDA 219440
ALApproval Letter
Approval Letter ALKEM LABS LTD (Feb 11, 2026)
FDA posted an approval letter for MIRABEGRON on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219323 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• MIRABEGRON
ALApproval Letter
Approval Letter EPIC PHARMA LLC (Feb 11, 2026)
FDA posted an approval letter for TAPENTADOL HYDROCHLORIDE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 214378 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• TAPENTADOL HYDROCHLORIDE
TATentative Approval Letter
Tentative Approval Letter AUROBINDO PHARMA (Feb 11, 2026)
FDA posted a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 11, 2026
US FDA• GLYCEROL PHENYLBUTYRATE

Page 139 of 152

1…137 138 139 140 141…152

Approval Letter ASPEN (Feb 12, 2026)

Approval Letter PFIZER (Feb 12, 2026)

Approval Letter EMERGENT (Feb 12, 2026)

Approval Letter PFIZER (Feb 12, 2026)

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)