Montelukast Sodium

ANDA 79103, held by Pharmobedient. Montelukast Sodium.

As of Nov 15, 2026, ANDA 79103 (Montelukast Sodium), held by Pharmobedient, 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

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	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Aug 18, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Oct 22, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Oct 22, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Oct 8, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 16, 2015	Supplement 4Labeling · 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 79103
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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