Xyntha

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC🇺🇸 United States

FDA Page

Effective Date: Mar 16, 2026
Approval ID: 25ea1c3c-14a2-ef11-302e-012bd683924f
Products: 5 registered
Version: 35

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA SOLOFUSE (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection Initial U.S. Approval: 2008

Quick Stats

Total Products5

Labelers1

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.