Montelukast Sodium

ANDA 207464, held by Chartwell Molecular. Montelukast Sodium.

As of Nov 15, 2026, ANDA 207464 (Montelukast Sodium), held by Chartwell Molecular, was first approved by FDA on Dec 6, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2018
Review: Standard
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
Dec 6, 2018	Original application	Approved	None posted

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 5 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jul 23, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jul 23, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jul 23, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Dec 6, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 207464
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