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US Department of Justice
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078523

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NDA 078523 describes VALPROATE SODIUM, which is a drug marketed by Athenex Inc, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in three NDAs. It is available from two suppliers. Additional details are available on the VALPROATE SODIUM profile page.

The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.
Summary for 078523
Tradename:VALPROATE SODIUM
Applicant:Hikma Farmaceutica
Ingredient:valproate sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078523
Suppliers and Packaging for NDA: 078523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 078523 ANDA West-Ward Pharmaceuticals Corp 0143-9637 0143-9637-10 10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)
VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 078523 ANDA West-Ward Pharmaceuticals Corp 0143-9785 0143-9785-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9785-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0143-9785-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Feb 17, 2010TE:APRLD:No

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Cerilliant
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