Details for New Drug Application (NDA): 021168

✉ Email this page to a colleague

NDA 021168 describes DEPAKOTE ER, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the DEPAKOTE ER profile page.

The generic ingredient in DEPAKOTE ER is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for 021168

Tradename:	DEPAKOTE ER
Applicant:	Abbvie
Ingredient:	divalproex sodium
Patents:	0

Pharmacology for NDA: 021168

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 021168

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168	NDA	AbbVie Inc.	0074-7401	0074-7401-13	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13)
DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168	NDA	AbbVie Inc.	0074-7402	0074-7402-13	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7402-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 500MG VALPROIC ACID
Approval Date:	Aug 4, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 250MG VALPROIC ACID
Approval Date:	May 31, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021168

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	⤷ Subscribe	⤷ Subscribe
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	⤷ Subscribe	⤷ Subscribe
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	⤷ Subscribe	⤷ Subscribe
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	⤷ Subscribe	⤷ Subscribe
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.