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 373-384 of 1819 letters

ALApproval Letter
Approval Letter CHEPLAPHARM (Oct 1, 2026)
FDA posted an approval letter for XENICAL on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020766 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• XENICAL
ALApproval Letter
Approval Letter CELLTRION INC (Oct 1, 2026)
FDA posted an approval letter for AVTOZMA on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761420 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• AVTOZMA
ALApproval Letter
Approval Letter MSD MERCK CO (Oct 1, 2026)
FDA posted an approval letter for DELSTRIGO on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210807 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• DELSTRIGO
ALApproval Letter
Approval Letter CELLTRION INC (Oct 1, 2026)
FDA posted an approval letter for EYDENZELT on 2026-10-01. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761377 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAOct 1, 2026
US FDA• EYDENZELT
WLWarning Letter
Warning Letter The Platinum Healthcare LLC (Oct 1, 2026)
FDA issued a warning letter to The Platinum Healthcare LLC concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Bioactive Services USA, LLC / Herstat Inc. (Oct 1, 2026)
FDA issued a warning letter to Bioactive Services USA, LLC / Herstat Inc. concerning Unapproved New Drugs. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter DesBio/Deseret Biologicals, Inc. (Oct 1, 2026)
FDA issued a warning letter to DesBio/Deseret Biologicals, Inc. concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Amazon.com, Inc. (Oct 1, 2026)
FDA issued a warning letter to Amazon.com, Inc. concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter OrganiCare, LLC / OrganiCare Nature’s Science, LLC (Oct 1, 2026)
FDA issued a warning letter to OrganiCare, LLC / OrganiCare Nature’s Science, LLC concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Walmart, Inc. (Oct 1, 2026)
FDA issued a warning letter to Walmart, Inc. concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Aidance Scientific, Inc. (Oct 1, 2026)
FDA issued a warning letter to Aidance Scientific, Inc. concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs
WLWarning Letter
Warning Letter Graceful Touch, LLC (Oct 1, 2026)
FDA issued a warning letter to Graceful Touch, LLC concerning Unapproved New Drugs. 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.
IssuedOct 1, 2026
US FDA• Unapproved New Drugs

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Approval Letter CHEPLAPHARM (Oct 1, 2026)

Approval Letter CELLTRION INC (Oct 1, 2026)

Approval Letter MSD MERCK CO (Oct 1, 2026)

Approval Letter CELLTRION INC (Oct 1, 2026)

Warning Letter The Platinum Healthcare LLC (Oct 1, 2026)

Warning Letter Bioactive Services USA, LLC / Herstat Inc. (Oct 1, 2026)

Warning Letter DesBio/Deseret Biologicals, Inc. (Oct 1, 2026)

Warning Letter Amazon.com, Inc. (Oct 1, 2026)

Warning Letter OrganiCare, LLC / OrganiCare Nature’s Science, LLC (Oct 1, 2026)

Warning Letter Walmart, Inc. (Oct 1, 2026)

Warning Letter Aidance Scientific, Inc. (Oct 1, 2026)

Warning Letter Graceful Touch, LLC (Oct 1, 2026)