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 1225-1236 of 1819 letters

ALApproval Letter
Approval Letter HALEON US HOLDINGS (May 4, 2026)
FDA posted an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 4, 2026
US FDA• CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED
ALApproval Letter
Approval Letter HALEON US HOLDINGS (May 4, 2026)
FDA posted an approval letter for CHILDREN'S ADVIL, JUNIOR STRENGTH ADVIL on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020944 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 4, 2026
US FDA• CHILDREN'S ADVIL / JUNIOR STRENGTH ADVIL
ALApproval Letter
Approval Letter HQ SPCLT PHARMA (May 4, 2026)
FDA posted an approval letter for DEXMEDETOMIDINE HYDROCHLORIDE on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 206628 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 4, 2026
US FDA• DEXMEDETOMIDINE HYDROCHLORIDE
ALApproval Letter
Approval Letter APOTEX (May 4, 2026)
FDA posted an approval letter for EVDI on 2026-05-04. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220837 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 4, 2026
US FDA• EVDI
WLWarning Letter
Warning Letter Naseem A. Jaffrani, M.D. (May 4, 2026)
FDA issued a warning letter to Naseem A. Jaffrani, 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 4, 2026
US FDA• Clinical Investigator
WLWarning Letter
Warning Letter IDO Pharm Co., Ltd. (May 4, 2026)
FDA issued a warning letter to IDO Pharm Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, 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 4, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Naveh Pharma LTD/Bigdam Inc. (May 4, 2026)
FDA issued a warning letter to Naveh Pharma LTD/Bigdam Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, Quality systems and CAPA, 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 4, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
ALApproval Letter
Approval Letter DAIICHI SANKYO INC (May 1, 2026)
FDA posted an approval letter for VANFLYTA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• VANFLYTA
ALApproval Letter
Approval Letter ASTRAZENECA AB (May 1, 2026)
FDA posted an approval letter for BREZTRI AEROSPHERE on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• BREZTRI AEROSPHERE
ALApproval Letter
Approval Letter ACADIA PHARMS INC (May 1, 2026)
FDA posted an approval letter for NUPLAZID on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 207318, NDA 210793 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• NUPLAZID
ALApproval Letter
Approval Letter SUNSHINE LAKE PHARMA CO LTD (May 1, 2026)
FDA posted an approval letter for LANGLARA on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761412 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• LANGLARA
ALApproval Letter
Approval Letter ASTRAZENECA (May 1, 2026)
FDA posted an approval letter for SYMBICORT AEROSPHERE on 2026-05-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216579 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 1, 2026
US FDA• SYMBICORT AEROSPHERE

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Approval Letter HALEON US HOLDINGS (May 4, 2026)

Approval Letter HALEON US HOLDINGS (May 4, 2026)

Approval Letter HQ SPCLT PHARMA (May 4, 2026)

Approval Letter APOTEX (May 4, 2026)

Warning Letter Naseem A. Jaffrani, M.D. (May 4, 2026)

Warning Letter IDO Pharm Co., Ltd. (May 4, 2026)

Warning Letter Naveh Pharma LTD/Bigdam Inc. (May 4, 2026)

Approval Letter DAIICHI SANKYO INC (May 1, 2026)

Approval Letter ASTRAZENECA AB (May 1, 2026)

Approval Letter ACADIA PHARMS INC (May 1, 2026)

Approval Letter SUNSHINE LAKE PHARMA CO LTD (May 1, 2026)

Approval Letter ASTRAZENECA (May 1, 2026)