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 601-612 of 1503 letters

ALApproval Letter
Approval Letter HIKMA PHARMS (Jun 18, 2026)
FDA issued an approval letter for PARICALCITOL on 2026-06-18. The source metadata identifies NDA 205917 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 18, 2026
US FDA• PARICALCITOL
ALApproval Letter
Approval Letter NORWICH (Jun 18, 2026)
FDA issued an approval letter for BALOXAVIR MARBOXIL on 2026-06-18. The source metadata identifies ANDA 217449 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 18, 2026
US FDA• BALOXAVIR MARBOXIL
ALApproval Letter
Approval Letter GENENTECH INC (Jun 18, 2026)
FDA issued an approval letter for OCREVUS ZUNOVO on 2026-06-18. The source metadata identifies BLA 761371 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 18, 2026
US FDA• OCREVUS ZUNOVO
ALApproval Letter
Approval Letter AZURITY (Jun 17, 2026)
FDA issued an approval letter for APREPITANT on 2026-06-17. The source metadata identifies NDA 218754 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 17, 2026
US FDA• APREPITANT
ALApproval Letter
Approval Letter SANDOZ (Jun 17, 2026)
FDA issued an approval letter for ARGATROBAN on 2026-06-17. The source metadata identifies NDA 020883 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 17, 2026
US FDA• ARGATROBAN
ALApproval Letter
Approval Letter KENVUE BRANDS (Jun 17, 2026)
FDA issued an approval letter for IMODIUM MULTI-SYMPTOM RELIEF on 2026-06-17. The source metadata identifies NDA 021140 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 17, 2026
US FDA• IMODIUM MULTI-SYMPTOM RELIEF
WLWarning Letter
Warning Letter Texinkart Inc. (Jun 17, 2026)
FDA issued a warning letter to Texinkart Inc. concerning Unapproved New Drugs/Misbranded. Deterministic source-metadata screening identifies discussion of 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.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Herbal Dermals LLC FZ dba Gotucream (Jun 17, 2026)
FDA issued a warning letter to Herbal Dermals LLC FZ dba Gotucream concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Hadassah Healing Oils Ltd (Jun 17, 2026)
FDA issued a warning letter to Hadassah Healing Oils Ltd concerning Unapproved New Drugs. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Telos Trading Limited dba Alwinshop (Jun 17, 2026)
FDA issued a warning letter to Telos Trading Limited dba Alwinshop concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Leading Edge Health Inc. (Jun 17, 2026)
FDA issued a warning letter to Leading Edge Health Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Amazon.com, Inc. (Jun 17, 2026)
FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedJun 17, 2026
US FDA• Unapproved New Drugs/Misbranded

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Approval Letter HIKMA PHARMS (Jun 18, 2026)

Approval Letter NORWICH (Jun 18, 2026)

Approval Letter GENENTECH INC (Jun 18, 2026)

Approval Letter AZURITY (Jun 17, 2026)

Approval Letter SANDOZ (Jun 17, 2026)

Approval Letter KENVUE BRANDS (Jun 17, 2026)

Warning Letter Texinkart Inc. (Jun 17, 2026)

Warning Letter Herbal Dermals LLC FZ dba Gotucream (Jun 17, 2026)

Warning Letter Hadassah Healing Oils Ltd (Jun 17, 2026)

Warning Letter Telos Trading Limited dba Alwinshop (Jun 17, 2026)

Warning Letter Leading Edge Health Inc. (Jun 17, 2026)

Warning Letter Amazon.com, Inc. (Jun 17, 2026)