Application 077567

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG VALPROIC ACID	No	No
002	DIVALPROEX SODIUM	DIVALPROEX SODIUM	TABLET, EXTENDED 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
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0472	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0473	Divalproex Sodium	divalproex sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7554	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7555	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8242	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8242	Divalproex Sodium	divalproex sodium	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-547	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-547	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-766	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
51079-767	Divalproex Sodium	divalproex sodium	Mylan Institutional Inc.	ANDA	Current
53808-0831	Divalproex Sodium	divalproex sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4381	Divalproex Sodium	divalproex sodium	Cardinal Health	ANDA	Current
67046-122	Divalproex Sodium	divalproex sodium	Contract Pharmacy Services-PA	ANDA	Current
71610-030	Divalproex Sodium	divalproex sodium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18466	ORIG	2009-02-24
31263	ORIG	2009-02-03

Application 077567

Related Records#

Application Products#

NDC Listings For This Application#

Documents#