VIVITROL

Alkermes, Inc.🇺🇸 United States

FDA Page

Effective Date: May 31, 2026
Approval ID: cd11c435-b0f0-4bb9-ae78-60f101f3703f
Products: 2 registered
Version: 39

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use VIVITROL safely and effectively. See full prescribing information for VIVITROL. VIVITROL (naltrexone for extended-release injectable suspension), for intramuscular useInitial U.S. Approval: 1984

Quick Stats

Total Products2

Labelers2

Label Sections21

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.