Montelukast Sodium

ANDA 201522, held by Chartwell Molecular. Montelukast Sodium.

As of Nov 15, 2026, ANDA 201522 (Montelukast Sodium), held by Chartwell Molecular, 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

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

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


Aug 7, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Aug 7, 2023	Supplement 18Labeling · 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 6Labeling · Standard review	Approved	None posted
Jan 6, 2016	Supplement 3Manufacturing	Approved	None posted
Aug 22, 2013	Supplement 4Labeling · 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 201522
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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