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Last Updated: March 17, 2025

Details for New Drug Application (NDA): 205695

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NDA 205695 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Norvium Bioscience, Teva Pharms, Torrent, Amneal Pharms, Anbison Lab, Apotex Inc, Chartwell Molecular, Hetero Labs Ltd V, Hikma, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Natco Pharma, Rising, Sandoz Inc, Strides Pharma, Torrent Pharms Ltd, Unichem, Unimark Remedies Ltd, Accord Hlthcare, Apotex Corp, Breckenridge, Cipla, Glenmark Pharms Ltd, and L Perrigo Co, and is included in forty-nine NDAs. It is available from thirty-seven 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-eight suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 205695

Tradename:	MONTELUKAST SODIUM
Applicant:	Anbison Lab
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:	Nov 5, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Nov 5, 2015	TE:	AB	RLD:	No

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