DABIGATRAN

American Health Packaging🇺🇸 United States

FDA Page

Effective Date: Jul 15, 2026
Approval ID: f7ea7e2c-ca54-4ecc-9fc7-bd3571b0ebc2
Products: 2 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010

Quick Stats

Total Products2

Labelers1

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.