Montelukast Sodium

Treats asthma. ANDA 203328, held by Ajanta Pharma Ltd. Montelukast Sodium.

As of Nov 15, 2026, ANDA 203328 (Montelukast Sodium), held by Ajanta Pharma Ltd, was first approved by FDA on Jul 31, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2015
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Montelukast sodium tablets, chewable tablets, and oral granules are a leukotriene receptor antagonist indicated for:

Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months of age and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 31, 2015	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Jul 1, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 20, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jul 31, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203328
Drugs@FDA: Overview at FDA
Company: Ajanta Pharma

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