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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204604

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NDA 204604 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Pharmobedient, Teva Pharms, Torrent, Aiping Pharm Inc, Amneal Pharms, Anbison Lab, Anda Repository, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Natco Pharma, Pharmaco, Rising, Torrent Pharms Ltd, Unichem, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, L Perrigo Co, Sandoz Inc, and Strides Pharma Intl, and is included in forty-nine NDAs. It is available from thirty-eight suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 204604

Tradename:	MONTELUKAST SODIUM
Applicant:	Amneal Pharms
Ingredient:	montelukast sodium
Patents:	0

Pharmacology for NDA: 204604

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 204604

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	204604	ANDA	Amneal Pharmaceuticals LLC	65162-732	65162-732-03	30 TABLET in 1 BOTTLE (65162-732-03)
MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	204604	ANDA	Amneal Pharmaceuticals LLC	65162-732	65162-732-09	90 TABLET in 1 BOTTLE (65162-732-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Sep 4, 2015	TE:	AB	RLD:	No

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