BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Argus Health
Julphar
Teva
Cantor Fitzgerald
Dow
US Department of Justice
Harvard Business School
Express Scripts

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078919

« Back to Dashboard

NDA 078919 describes DIVALPROEX SODIUM, which is a drug marketed by Dr Reddys Labs Ltd, Mylan, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Anchen Pharms, Aurobindo Pharma Ltd, Lupin, Nu Pharm, Orchid Hlthcare, Prinston Inc, Sandoz, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher-smith Labs, Wockhardt, Amneal Pharms, G And W Labs Inc, Impax Labs, and Reddys, and is included in thirty NDAs. It is available from forty-eight suppliers. Additional details are available on the DIVALPROEX SODIUM profile page.

The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are seventeen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078919
Tradename:DIVALPROEX SODIUM
Applicant:Zydus Pharms Usa Inc
Ingredient:divalproex sodium
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078919
Suppliers and Packaging for NDA: 078919
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 078919 ANDA AvPAK 50268-258 50268-258-13 30 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-258-13) > 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (50268-258-11)
DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 078919 ANDA Cardinal Health 55154-4759 55154-4759-0 10 BLISTER PACK in 1 BAG (55154-4759-0) > 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Jan 27, 2009TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
McKinsey
Chubb
Fish and Richardson
Daiichi Sankyo
Accenture
Baxter
QuintilesIMS

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.

botpot