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 577-588 of 1503 letters

ALApproval Letter
Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)
FDA issued an approval letter for NUCYNTA ER on 2026-06-23. The source metadata identifies NDA 200533 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• NUCYNTA ER
ALApproval Letter
Approval Letter KNOA PHARMA (Jun 23, 2026)
FDA issued an approval letter for HYSINGLA ER on 2026-06-23. The source metadata identifies NDA 206627 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• HYSINGLA ER
ALApproval Letter
Approval Letter KNOA PHARMA (Jun 23, 2026)
FDA issued an approval letter for OXYCONTIN on 2026-06-23. The source metadata identifies NDA 022272 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• OXYCONTIN
ALApproval Letter
Approval Letter GENENTECH INC (Jun 23, 2026)
FDA issued an approval letter for LUNSUMIO, LUNSUMIO VELO on 2026-06-23. The source metadata identifies BLA 761263 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• LUNSUMIO / LUNSUMIO VELO
ALApproval Letter
Approval Letter HIKMA (Jun 23, 2026)
FDA issued an approval letter for CODEINE SULFATE on 2026-06-23. The source metadata identifies NDA 202245 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• CODEINE SULFATE
ALApproval Letter
Approval Letter AGILE (Jun 23, 2026)
FDA issued an approval letter for TWIRLA on 2026-06-23. The source metadata identifies NDA 204017 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 23, 2026
US FDA• TWIRLA
WLWarning Letter
Warning Letter LyfeUnit / www.lyfeunit.com (Jun 23, 2026)
FDA issued a warning letter to LyfeUnit / www.lyfeunit.com 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 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Ketamine Troche Store / www.ketaminetrochestore.com (Jun 23, 2026)
FDA issued a warning letter to Ketamine Troche Store / www.ketaminetrochestore.com concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com (Jun 23, 2026)
FDA issued a warning letter to Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com 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 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Med Shop Inc / www.medshopinc.com (Jun 23, 2026)
FDA issued a warning letter to Med Shop Inc / www.medshopinc.com 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 23, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Allandale Dairy (Jun 23, 2026)
FDA issued a warning letter to Allandale Dairy concerning New Animal Drug/Adulterated. Deterministic full-text 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 23, 2026
US FDA• New Animal Drug/Adulterated
WLWarning Letter
Warning Letter Keta Med Lab / www.ketamedlab.com (Jun 23, 2026)
FDA issued a warning letter to Keta Med Lab / www.ketamedlab.com 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 23, 2026
US FDA• Unapproved New Drugs/Misbranded

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Approval Letter COLLEGIUM PHARM INC (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter KNOA PHARMA (Jun 23, 2026)

Approval Letter GENENTECH INC (Jun 23, 2026)

Approval Letter HIKMA (Jun 23, 2026)

Approval Letter AGILE (Jun 23, 2026)

Warning Letter LyfeUnit / www.lyfeunit.com (Jun 23, 2026)

Warning Letter Ketamine Troche Store / www.ketaminetrochestore.com (Jun 23, 2026)

Warning Letter Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com (Jun 23, 2026)

Warning Letter Med Shop Inc / www.medshopinc.com (Jun 23, 2026)

Warning Letter Allandale Dairy (Jun 23, 2026)

Warning Letter Keta Med Lab / www.ketamedlab.com (Jun 23, 2026)