Application 078723

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONTELUKAST SODIUM	MONTELUKAST SODIUM	TABLET, CHEWABLE;ORAL	EQ 4MG BASE	No	No
002	MONTELUKAST SODIUM	MONTELUKAST SODIUM	TABLET, CHEWABLE;ORAL	EQ 5MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7424	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7425	Montelukast Sodium	Montelukast Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
68151-4186	Montelukast Sodium	Montelukast Sodium	Carilion Materials Management	ANDA	Current
68151-4338	Montelukast Sodium	Montelukast Sodium	Carilion Materials Management	ANDA	Current
71335-0611	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current
71335-0611	Montelukast Sodium	Montelukast Sodium	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31384	ORIG	2012-08-06