Montelukast Sodium

ANDA 201294, held by Apotex Corp. Montelukast Sodium.

As of Nov 15, 2026, ANDA 201294 (Montelukast Sodium), held by Apotex Corp, was first approved by FDA on Aug 3, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 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	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 16, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Aug 14, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Dec 13, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 201294
Drugs@FDA: Overview at FDA
Company: Apotex

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