Details for New Drug Application (NDA): 018723

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NDA 018723 describes DEPAKOTE, which is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from one supplier. Additional details are available on the DEPAKOTE profile page.

The generic ingredient in DEPAKOTE 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 018723

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

Pharmacology for NDA: 018723

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 018723

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723	NDA	AbbVie Inc.	0074-7325	0074-7325-13	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7325-13)
DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723	NDA	AbbVie Inc.	0074-7326	0074-7326-13	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7326-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 250MG VALPROIC ACID
Approval Date:	Mar 10, 1983	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 500MG VALPROIC ACID
Approval Date:	Mar 10, 1983	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 125MG VALPROIC ACID
Approval Date:	Oct 26, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018723

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-002	Mar 10, 1983	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-001	Mar 10, 1983	⤷ Sign Up	⤷ Sign Up
Abbvie	DEPAKOTE	divalproex sodium	TABLET, DELAYED RELEASE;ORAL	018723-003	Oct 26, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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