Application 078597

Type: ANDA
Sponsor: SUN PHARM INDS

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 Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6860	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6860	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6860	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6861	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6861	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
0904-6861	Divalproex Sodium	Divalproex Sodium	Major Pharmaceuticals	ANDA	Current
17856-0797	Divalproex Sodium	Divalproex Sodium	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0798	Divalproex Sodium	Divalproex Sodium	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
33261-641	Divalproex Sodium	Divalproex Sodium	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-2336	Divalproex Sodium	Divalproex Sodium	Cardinal Health	ANDA	Current
55154-2336	Divalproex Sodium	Divalproex Sodium	Cardinal Health 107, LLC	ANDA	Current
55154-4154	Divalproex Sodium	Divalproex Sodium	Cardinal Health 107, LLC	ANDA	Current
61919-648	DIVALPROEX SODIUM	DIVALPROEX SODIUM	DIRECT RX	ANDA	Current
61919-648	DIVALPROEX SODIUM	DIVALPROEX SODIUM	DIRECT RX	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-796	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-797	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-798	Divalproex Sodium	Divalproex Sodium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
64725-0797	Divalproex Sodium	Divalproex Sodium	TYA Pharmaceuticals	ANDA	Current
64725-0798	Divalproex Sodium	Divalproex Sodium	TYA Pharmaceuticals	ANDA	Current
67046-105	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
67046-145	Divalproex Sodium	Divalproex Sodium	Contract Pharmacy Services-PA	ANDA	Current
68001-554	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-555	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68001-556	Divalproex Sodium	Divalproex Sodium	BluePoint Laboratories	ANDA	Current
68151-1164	Divalproex Sodium	Divalproex Sodium	Carilion Materials Management	ANDA	Current
70518-0374	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0374	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0374	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0374	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0374	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-0463	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-1558	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2513	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2513	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2513	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2513	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2513	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2665	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2665	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2665	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2665	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2665	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2674	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2674	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2674	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2674	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2674	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-3431	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current
70518-3431	Divalproex Sodium	Divalproex Sodium	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9171	ORIG	2008-08-05

Application 078597

Related Records#

Application Products#

NDC Listings For This Application#

Documents#