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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 five 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 seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for NDA: 018723

Tradename:
DEPAKOTE
Applicant:
Abbvie
Ingredient:
divalproex sodium
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018723

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. 0074-6212 0074-6212-13 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-6212-13)
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 018723 NDA AbbVie Inc. 0074-6214 0074-6214-13 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-6214-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Mar 10, 1983TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Mar 10, 1983TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Oct 26, 1984TE:ABRLD:No

Expired Orange Book Patents for NDA: 018723

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL018723-003Oct 26, 19844,988,731*PED► subscribe
Abbvie
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL018723-002Mar 10, 19834,988,731*PED► subscribe
Abbvie
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL018723-001Mar 10, 19835,212,326*PED► subscribe
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