Montelukast Sodium

Bryant Ranch Prepack🇺🇸 United States

FDA Page

Effective Date: Dec 23, 2021
Approval ID: b8b86f2b-1fe3-4a58-9bf4-e826166609c3
Products: 1 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998

Quick Stats

Total Products1

Labelers2

Label Sections19

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.