Montelukast Sodium

Treats asthma. ANDA 204290, held by Unichem. Montelukast Sodium.

As of Nov 15, 2026, ANDA 204290 (Montelukast Sodium), held by Unichem, was first approved by FDA on Oct 8, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 8, 2015
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Oct 8, 2015	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Jun 28, 2023	Supplement 26Labeling · Standard review	Approved	None posted
Jun 28, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Jun 28, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Jun 28, 2023	Supplement 12Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Apr 19, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Apr 19, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Oct 8, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204290
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

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