BIVALIRUDIN

Eugia US LLC🇺🇸 United States

FDA Page

Effective Date: Jul 10, 2026
Approval ID: e574d04f-67b4-4a84-9d66-8c2d54f95120
Products: 1 registered
Version: 9

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

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

Quick Stats

Total Products1

Labelers2

Label Sections17

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.