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Last Updated: November 4, 2024

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, 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-nine 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. Forty 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

Pharmacology for NDA: 209011

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 209011

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	209011	ANDA	Graviti Pharmaceuticals Private Limited	69844-074	69844-074-01	30 TABLET, CHEWABLE in 1 BOTTLE (69844-074-01)
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	209011	ANDA	Graviti Pharmaceuticals Private Limited	69844-074	69844-074-02	100 TABLET, CHEWABLE in 1 BOTTLE (69844-074-02)

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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