Acamprosate Calcium

American Health Packaging🇺🇸 United States

FDA Page

Effective Date: Aug 26, 2025
Approval ID: 94ef2a5c-cc2f-4e7f-b159-b2d38188d5b8
Products: 1 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS. ACAMPROSATE CALCIUM delayed-release tablets, for oral use Initial U.S. Approval: 2004

Quick Stats

Total Products1

Labelers2

Label Sections20

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.