Montelukast Sodium

Treats asthma. ANDA 201582, held by Dr Reddys Labs Ltd. Montelukast Sodium.

As of Nov 15, 2026, ANDA 201582 (Montelukast Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Aug 6, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 6, 2012
Supplements approved: 11
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 12 submissions below

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

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Nov 27, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Nov 10, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Aug 6, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Feb 19, 2013	Supplement 3Labeling · 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 201582
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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