XARELTO

Janssen Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 10, 2026
Approval ID: 10db92f9-2300-4a80-836b-673e1ae91610
Products: 6 registered
Version: 65

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

Quick Stats

Total Products6

Labelers2

Label Sections47

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.