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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Queensland Health
Fish and Richardson
Johnson and Johnson

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078919

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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, Apotex Inc, Aurobindo Pharma Ltd, Lupin, 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-three 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. Forty-six suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078919
Applicant:Zydus Pharms Usa Inc
Ingredient:divalproex sodium
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 N 50268-258-13
DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 078919 ANDA Cardinal Health 55154-4759 N 55154-4759-0

Profile for product number 001

Approval Date:Jan 27, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson

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