Tracleer

Actelion Pharmaceuticals US, Inc.🇺🇸 United States

FDA Page

Effective Date: Nov 17, 2025
Approval ID: 749e42fb-2fe0-45dd-9268-b43bb3f4081c
Products: 4 registered
Version: 32

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TRACLEER safely and effectively. See full prescribing information for TRACLEER. TRACLEER (bosentan) tablets, for oral use TRACLEER (bosentan) tablets for oral suspension Initial U.S. Approval: 2001

Quick Stats

Total Products4

Labelers2

Label Sections43

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.