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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 203328

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NDA 203328 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 forty 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-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for 203328

Tradename:	MONTELUKAST SODIUM
Applicant:	Ajanta Pharma Ltd
Ingredient:	montelukast sodium
Patents:	0

Pharmacology for NDA: 203328

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 203328

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203328	ANDA	Ajanta Pharma USA Inc.	27241-016	27241-016-03	30 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03)
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	203328	ANDA	Ajanta Pharma USA Inc.	27241-016	27241-016-09	90 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Jul 31, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 31, 2015	TE:		RLD:	No

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