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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091414

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NDA 091414 describes MONTELUKAST SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan Pharms Inc, Teva Pharms, Anbison Lab Co Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Hetero Labs Ltd V, Jubilant Generics, Kremers Urban Pharms, Macleods Pharms Ltd, Sandoz Inc, Torrent Pharms Ltd, Unimark Remedies Ltd, Vintage Pharms Llc, West-ward Pharms Int, Accord Hlthcare, Amneal Pharms, Apotex Corp, Cipla Ltd, Glenmark Generics, Perrigo R And D, and Unichem Labs Ltd, and is included in forty-three NDAs. It is available from fifty-seven suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

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

Summary for 091414

Tradename:	MONTELUKAST SODIUM
Applicant:	Sandoz Inc
Ingredient:	montelukast sodium
Patents:	0
Therapeutic Class:	Respiratory Tract Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 091414

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 091414

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	091414	ANDA	Sandoz Inc	0781-5554	N	0781-5554-13
MONTELUKAST SODIUM	montelukast sodium	TABLET, CHEWABLE;ORAL	091414	ANDA	Sandoz Inc	0781-5554	N	0781-5554-64

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Aug 3, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 3, 2012	TE:	AB	RLD:	No

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