Montelukast Sodium

Treats asthma. ANDA 203366, held by Macleods Pharms. Montelukast Sodium.

As of Nov 15, 2026, ANDA 203366 (Montelukast Sodium), held by Macleods Pharms, was first approved by FDA on Sep 11, 2014, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2014
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 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 9 submissions below

Date	Submission	Status	Documents
Sep 11, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Montelukast SodiumEQ 10MG BASE · tablet;oral	Montelukast Sodium	Rx

All 9 submissions, including labeling and manufacturing supplements


Sep 27, 2024	Supplement 34Labeling · Standard review	Approved	None posted
Sep 27, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Jun 7, 2023	Supplement 30Labeling · Standard review	Approved	None posted
Nov 24, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 13Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Jun 23, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Sep 11, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203366
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