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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 209011

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NDA 209011 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 209011

Tradename:	MONTELUKAST SODIUM
Applicant:	Rising
Ingredient:	montelukast sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Apr 18, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Apr 18, 2017	TE:	AB	RLD:	No

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