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 1093-1104 of 1819 letters

ALApproval Letter
Approval Letter ASTRAZENECA (May 29, 2026)
FDA posted an approval letter for TRUQAP on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218197 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 29, 2026
US FDA• TRUQAP
ALApproval Letter
Approval Letter ORGANON (May 29, 2026)
FDA posted an approval letter for IMPLANON, NEXPLANON on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021529 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 29, 2026
US FDA• IMPLANON / NEXPLANON
ALApproval Letter
Approval Letter AZURITY (May 29, 2026)
FDA posted an approval letter for XATMEP on 2026-05-29. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 208400 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 29, 2026
US FDA• XATMEP
WLWarning Letter
Warning Letter Macau-Union Pharmaceutical Limited (May 29, 2026)
FDA issued a warning letter to Macau-Union Pharmaceutical Limited concerning Nonprescription/OTC. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 29, 2026
US FDA• Nonprescription/OTC
WLWarning Letter
Warning Letter Jubilant HollisterStier General Partnership (May 28, 2026)
FDA issued a warning letter to Jubilant HollisterStier General Partnership concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, 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.
IssuedMay 28, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Medline Inc (May 28, 2026)
FDA issued a warning letter to Medline Inc concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing, 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.
IssuedMay 28, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Jose M. Carpio, M.D. (May 28, 2026)
FDA issued a warning letter to Jose M. Carpio, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 28, 2026
US FDA• Clinical Investigator
ALApproval Letter
Approval Letter UCB INC (May 27, 2026)
FDA posted an approval letter for FINTEPLA on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212102 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• FINTEPLA
ALApproval Letter
Approval Letter SENTYNL THERAPS INC (May 27, 2026)
FDA posted an approval letter for NULIBRY on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214018 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• NULIBRY
ALApproval Letter
Approval Letter ASTRAZENECA (May 27, 2026)
FDA posted an approval letter for KOSELUGO on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 213756, NDA 219943 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• KOSELUGO
ALApproval Letter
Approval Letter ASTRAZENECA (May 27, 2026)
FDA posted an approval letter for CRESTOR on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021366 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• CRESTOR
ALApproval Letter
Approval Letter DAIICHI SANKYO INC (May 27, 2026)
FDA posted an approval letter for DATROWAY on 2026-05-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 27, 2026
US FDA• DATROWAY

Page 92 of 152

1…90 91 92 93 94…152

Approval Letter ASTRAZENECA (May 29, 2026)

Approval Letter ORGANON (May 29, 2026)

Approval Letter AZURITY (May 29, 2026)

Warning Letter Macau-Union Pharmaceutical Limited (May 29, 2026)

Warning Letter Jubilant HollisterStier General Partnership (May 28, 2026)

Warning Letter Medline Inc (May 28, 2026)

Warning Letter Jose M. Carpio, M.D. (May 28, 2026)

Approval Letter UCB INC (May 27, 2026)

Approval Letter SENTYNL THERAPS INC (May 27, 2026)

Approval Letter ASTRAZENECA (May 27, 2026)

Approval Letter ASTRAZENECA (May 27, 2026)

Approval Letter DAIICHI SANKYO INC (May 27, 2026)