ANDEXXA

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: May 23, 2025
Approval ID: 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ANDEXXA safely and effectively. See Full Prescribing Information for ANDEXXA. ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) Lyophilized powder for solution for intravenous injection Initial U.S. Approval: 2018

Quick Stats

Total Products1

Labelers2

Label Sections36

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.