ZILEUTON

Lupin Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 13, 2020
Approval ID: cf392f79-2276-4fe1-8fa8-74afd5150f73
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 ZILEUTON EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ZILEUTON EXTENDED-RELEASE TABLETS. ZILEUTON extended-release tablets, for oral use.Initial U.S. Approval: 1996

Quick Stats

Total Products1

Labelers2

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.