TEVA Application 076941

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
003	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 500MG VALPROIC ACID	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7439	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7440	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7441	Divalproex Sodium	Divalproex Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39520	ORIG	2008-11-20
31177	ORIG	2008-08-01