RADICAVA

Mitsubishi Tanabe Pharma America, Inc.🇺🇸 United States

FDA Page

Effective Date: May 5, 2026
Approval ID: 0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11
Products: 3 registered
Version: 29

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS. RADICAVA (edaravone) injection, for intravenous use RADICAVA ORS (edaravone) oral suspension Initial U.S. Approval: 2017

Quick Stats

Total Products3

Labelers4

Label Sections35

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.