Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules for oral use Initial U.S. Approval: 2010
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.
