MONTELUKAST

Proficient Rx LP🇺🇸 United States

FDA Page

Effective Date: Nov 1, 2019
Approval ID: 9705627c-283e-4743-b261-cfeb88d96e9b
Products: 1 registered
Version: 3

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 and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use.Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998

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.