Bivalirudin

Athenex Pharmaceutical Division, LLC.🇺🇸 United States

FDA Page

Effective Date: Mar 2, 2024
Approval ID: 1ed8c822-6fe1-49c1-a59f-31a4c72818c8
Products: 1 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BIVALIRUDIN RTU INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN RTU INJECTION. BIVALIRUDIN RTU (bivalirudin) injection, for intravenous use Initial U.S. Approval: 2000

Quick Stats

Total Products1

Labelers2

Label Sections32

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.