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Serving leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Queensland Health

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078979

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NDA 078979 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 078979

Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078979

Suppliers and Packaging for NDA: 078979

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 078979 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1393 0615-1393-05 15 CAPSULE in 1 BLISTER PACK (0615-1393-05)
DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 078979 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1393 0615-1393-39 30 CAPSULE in 1 BLISTER PACK (0615-1393-39)

Summary for product number 001

Approval Date:Jan 23, 2009TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Johnson and Johnson
US Department of Justice
Federal Trade Commission
Farmers Insurance

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