rivaroxaban

Changzhou Pharmaceutical Factory🇺🇸 United States

FDA Page

Effective Date: Dec 11, 2025
Approval ID: 9178947d-9d58-4c1a-b158-6030e17556af
Products: 3 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use RIVAROXABAN TABLETS safely and effectively. See full prescribing information for RIVAROXABAN TABLETS. RIVAROXABAN tablets, for oral use Initial U.S. Approval: 2011

Quick Stats

Total Products3

Labelers1

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.