Montelukast Sodium

Treats asthma. ANDA 200405, held by Lannett Co Inc. Montelukast Sodium.

As of Nov 15, 2026, ANDA 200405 (Montelukast Sodium), held by Lannett Co Inc, was first approved by FDA on Aug 3, 2012, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2012
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Montelukast sodium tablets 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. 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. 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 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 12 submissions, including labeling and manufacturing supplements


Jun 26, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jun 26, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Oct 8, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Oct 8, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 8, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Jul 23, 2018	Supplement 9Labeling · Standard review	Approved	None posted
Jun 2, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jun 2, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Aug 20, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Sep 18, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 200405
Drugs@FDA: Overview at FDA
Company: Lannett Company

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