Application 077132

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	5MG	No	No
002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	30MG	No	No
003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	TABLET;ORAL	35MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3098	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3099	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-3100	Risedronate Sodium	Risedronate Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44342	ORIG	2007-10-23
18456	ORIG	2007-10-10
9006	ORIG	2007-10-10