Xofluza

A-S Medication Solutions🇺🇸 United States

FDA Page

Effective Date: Apr 16, 2021
Approval ID: e9e6990a-66d3-4e13-b823-ff04d2d65886
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XOFLUZA safely and effectively. See full prescribing information for XOFLUZA. XOFLUZA (baloxavir marboxil) tablets, for oral use XOFLUZA (baloxavir marboxil) for oral suspension Initial U.S. Approval: 2018

Quick Stats

Total Products1

Labelers2

Label Sections41

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.