Montelukast Sodium

Treats asthma. ANDA 201581, held by Pharmazone. Montelukast Sodium.

As of Nov 15, 2026, ANDA 201581 (Montelukast Sodium), held by Pharmazone, was first approved by FDA on Aug 6, 2012, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 6, 2012
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 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 9 submissions below

Date	Submission	Status	Documents
Aug 6, 2012	Original application	Approved	None posted

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 9 submissions, including labeling and manufacturing supplements


Nov 27, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Aug 6, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Feb 5, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Dec 10, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Aug 6, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201581
Drugs@FDA: Overview at FDA
Company: Pharmazone

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