Coagadex

Bio Products Laboratory Limited🇺🇸 United States

FDA Page

Effective Date: Apr 13, 2026
Approval ID: ad20e6ff-98bc-47e6-aa00-7fb441edd2b0
Products: 2 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use COAGADEX safely and effectively. See full prescribing information for COAGADEX. COAGADEX (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: [2015]

Quick Stats

Total Products2

Labelers2

Label Sections25

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.