Montelukast Sodium

ANDA 202906, held by Dr Reddys Labs Ltd. Montelukast Sodium.

As of Nov 15, 2026, ANDA 202906 (Montelukast Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Sep 17, 2012, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 17, 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
Sep 17, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Montelukast SodiumEQ 4MG BASE/PACKET · granule;oral	Montelukast Sodium	Rx

All 10 submissions, including labeling and manufacturing supplements


Nov 5, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Nov 7, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Nov 7, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 7, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 7, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Nov 7, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Aug 14, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Jan 31, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 1Labeling · Standard review	Approved	None posted
Sep 17, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202906
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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