Kovaltry

Bayer HealthCare LLC🇺🇸 United States

FDA Page

Effective Date: Mar 2, 2026
Approval ID: 89ba5048-469c-4f08-a173-81b0c6f3004d
Products: 5 registered
Version: 18

Regulatory Information

Labeling Type

PLASMA DERIVATIVE

Status

Approved

Full Title

These highlights do not include all the information needed to use KOVALTRY safely and effectively. See full prescribing information for KOVALTRY.KOVALTRY [Antihemophilic Factor (Recombinant)]Lyophilized Powder for Solution for Intravenous Injection – Reconstitution with Vial AdapterInitial U.S. Approval: 2016

Quick Stats

Total Products5

Labelers1

Label Sections15

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.