Montelukast Sodium

Treats asthma. ANDA 201515, held by Torrent Pharms Ltd. Montelukast Sodium.

As of Nov 15, 2026, ANDA 201515 (Montelukast Sodium), held by Torrent Pharms Ltd, was first approved by FDA on Aug 3, 2012, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2012
Supplements approved: 9
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 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. 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 10 submissions below

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

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Apr 3, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Oct 15, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Oct 5, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Oct 5, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Mar 1, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jan 4, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Apr 7, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Jan 28, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Oct 16, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 201515
Drugs@FDA: Overview at FDA
Company: Torrent 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