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Generated: May 22, 2017

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Details for New Drug Application (NDA): 090161

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NDA 090161 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: 090161

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

Pharmacology for NDA: 090161

Suppliers and Packaging for NDA: 090161

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL 090161 ANDA Major Pharmaceuticals 0904-6363 0904-6363-45 80 BLISTER PACK in 1 CARTON (0904-6363-45) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL 090161 ANDA Dr. Reddy's Laboratories Ltd 55111-533 55111-533-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-533-01)

Summary for product number 001

Approval Date:Mar 15, 2012TE:ABRLD:No

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