Acthar

Mallinckrodt ARD LLC🇺🇸 United States

FDA Page

Effective Date: Jul 15, 2026
Approval ID: 7b48ddec-e815-45f4-9ca0-5c0daaf56f30
Products: 1 registered
Version: 29

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ACTHAR GEL safely and effectively. See full prescribing information for ACTHAR GEL. ACTHAR GEL (repository corticotropin injection), for intramuscular or subcutaneous use Initial U.S. Approval: 1952

Quick Stats

Total Products1

Labelers2

Label Sections18

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.