Montelukast Sodium

Treats asthma. ANDA 200889, held by Aiping Pharm Inc. Montelukast Sodium.

As of Nov 15, 2026, ANDA 200889 (Montelukast Sodium), held by Aiping Pharm Inc, 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 tablets are a leukotriene receptor antagonist indicated for:

Prophylaxis and chronic treatment of asthma in patients 15 years of age and older.
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 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 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


Jan 19, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Sep 4, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Sep 4, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Oct 1, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Jul 26, 2018	Supplement 10Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 9Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jun 26, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 200889
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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