Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Army
Moodys
Boehringer Ingelheim
Teva
Healthtrust
Cipla
US Department of Justice
Farmers Insurance

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078523

« Back to Dashboard

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 N 0143-9637-10
VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 078523 ANDA West-Ward Pharmaceuticals Corp 0143-9785 N 0143-9785-10

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Express Scripts
Deloitte
Daiichi Sankyo
Cerilliant
Boehringer Ingelheim
McKesson
Covington
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.