Montelukast Sodium

ANDA 78723, held by Teva Pharms. Montelukast Sodium.

As of Nov 15, 2026, ANDA 78723 (Montelukast Sodium), held by Teva Pharms, 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

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


May 20, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Jul 23, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Apr 1, 2020	Supplement 12Labeling · Standard review	Approved	None posted
May 18, 2018	Supplement 11Labeling · Standard review	Approved	None posted
Nov 12, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jun 25, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Feb 6, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Dec 13, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Oct 12, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 78723
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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