Montelukast Sodium

Treats asthma. ANDA 203582, held by Macleods Pharms. Montelukast Sodium.

As of Nov 15, 2026, ANDA 203582 (Montelukast Sodium), held by Macleods Pharms, was first approved by FDA on Mar 12, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 12, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Montelukast sodium chewable tablet is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies. Limitations of Use: Not indicated to treat an acute asthma attack. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 12, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Montelukast SodiumEQ 4MG BASE · tablet, chewable;oral	Montelukast Sodium	Rx
Montelukast SodiumEQ 5MG BASE · tablet, chewable;oral	Montelukast Sodium	Rx

All 8 submissions, including labeling and manufacturing supplements


Jul 31, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Jul 31, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Sep 25, 2015	Supplement 1Manufacturing	Approved	None posted
Mar 12, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203582
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters