Montelukast sodium

Macleods Pharmaceuticals Limited🇺🇸 United States

FDA Page

Effective Date: Jul 6, 2023
Approval ID: ce512844-5220-4661-809f-56d088699c9c
Products: 2 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 MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval 1998

Quick Stats

Total Products2

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.