Memantine Hydrochloride(HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS MEMANTINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 2003)

Macleods Pharmaceuticals Limited🇺🇸 United States

FDA Page

Effective Date: Dec 31, 2022
Approval ID: 989fa756-7d70-4ea7-bb5e-f4395e48589d
Products: 2 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS MEMANTINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 2003

Quick Stats

Total Products2

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.