OSMOLEX ER

Adamas Pharma, LLC🇺🇸 United States

FDA Page

Effective Date: Feb 8, 2024
Approval ID: 6fbddb66-8b9d-4d37-a348-abcc31276e89
Products: 2 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

OSMOLEX ®ER - These highlights do not include all the information needed to use OSMOLEX ER safely and effectively. See full prescribing information for OSMOLEX ER. OSMOLEX ER (amantadine) extended-release tablets, for oral use Initial U.S. Approval: 1966

Quick Stats

Total Products2

Labelers2

Label Sections37

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.