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Generated: November 20, 2018

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Details for New Drug Application (NDA): 019680

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NDA 019680 describes DEPAKOTE, which is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from three suppliers. There are six patents protecting this drug and two Paragraph IV challenges. 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-eight suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 019680
Tradename:DEPAKOTE
Applicant:Abbvie
Ingredient:divalproex sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019680
Suppliers and Packaging for NDA: 019680
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 NDA AbbVie Inc. 0074-6114 0074-6114-13 100 CAPSULE in 1 BOTTLE (0074-6114-13)
DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680 NDA AUTHORIZED GENERIC Sandoz Inc. 0781-2243 0781-2243-01 100 CAPSULE in 1 BOTTLE (0781-2243-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Sep 12, 1989TE:ABRLD:Yes

Expired US Patents for NDA 019680

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680-001 Sep 12, 1989 ➤ Sign Up ➤ Sign Up
Abbvie DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680-001 Sep 12, 1989 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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McKinsey
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