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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021168

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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-two 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

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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	6,713,086*PED	⤷ Get Started Free
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-002	May 31, 2002	6,528,091*PED	⤷ Get Started Free
Abbvie	DEPAKOTE ER	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	021168-001	Aug 4, 2000	6,528,090*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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