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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078605

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NDA 078605 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 078605

Tradename:	MONTELUKAST SODIUM
Applicant:	Teva Pharms
Ingredient:	montelukast sodium
Patents:	0

Pharmacology for NDA: 078605

Mechanism of Action	Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 078605

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MONTELUKAST SODIUM	montelukast sodium	TABLET;ORAL	078605	ANDA	Proficient Rx LP	63187-289	63187-289-30	30 TABLET, FILM COATED in 1 BOTTLE (63187-289-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 3, 2012	TE:	AB	RLD:	No

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