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Generated: April 29, 2017

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Details for New Drug Application (NDA): 078979

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NDA 078979 describes DIVALPROEX SODIUM, which is a drug marketed by Zydus Pharms Usa Inc, G And W Labs Inc, Wockhardt, Mylan, Prinston Inc, Anchen Pharms, Nu Pharm, Aurobindo Pharma Ltd, Amneal Pharms, Teva, Orchid Hlthcare, Dr Reddys Labs Ltd, Unichem Labs Ltd, Reddys, Actavis Labs Fl Inc, Upsher Smith, Lupin, Sandoz, Impax Labs, and Sun Pharm Inds, and is included in thirty NDAs. It is available from fifty 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-three suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for NDA: 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
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
CAPSULE, DELAYED REL PELLETS;ORAL 078979 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1393 0615-1393-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-1393-30) > 5 CAPSULE in 1 BLISTER PACK

Summary for product number 001

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

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