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Generated: November 20, 2018

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Details for New Drug Application (NDA): 018082

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NDA 018082 describes DEPAKENE, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEPAKENE profile page.

The generic ingredient in DEPAKENE is valproic acid. There are seventeen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 018082
Tradename:DEPAKENE
Applicant:Abbvie
Ingredient:valproic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018082
Medical Subject Heading (MeSH) Categories for 018082
Suppliers and Packaging for NDA: 018082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPAKENE valproic acid SYRUP;ORAL 018082 NDA AbbVie Inc. 0074-5682 0074-5682-16 473 mL in 1 BOTTLE (0074-5682-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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