Montelukast Sodium

Treats asthma. ANDA 202096, held by Aurobindo Pharma Ltd. Montelukast Sodium.

As of Nov 15, 2026, ANDA 202096 (Montelukast Sodium), held by Aurobindo Pharma Ltd, was first approved by FDA on Aug 3, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2012
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Montelukast sodium 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 11 submissions below

Date	Submission	Status	Documents
Aug 3, 2012	Original application	Approved	Letter

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 11 submissions, including labeling and manufacturing supplements


Jan 19, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Aug 14, 2020	Supplement 22Labeling · Standard review	Approved	None posted
Nov 5, 2019	Supplement 18Labeling · Standard review	Approved	None posted
Nov 5, 2019	Supplement 21Labeling · Standard review	Approved	None posted
Jul 23, 2018	Supplement 16Labeling · Standard review	Approved	None posted
Dec 8, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Dec 8, 2015	Supplement 13Labeling · Standard review	Approved	None posted
May 10, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 4Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 202096
Drugs@FDA: Overview at FDA
Company: Aurobindo 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