Lurasidone hydrochloride

Zydus Pharmaceuticals USA Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 28, 2026
Approval ID: bceb350e-4b88-4de1-9629-9629365a27a7
Products: 5 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LURASIDONE HYDROCHLORIDE TABLETS. LURASIDONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2010

Quick Stats

Total Products5

Labelers2

Label Sections21

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.