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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077567

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NDA 077567 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-nine 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-two suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for 077567

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077567

Suppliers and Packaging for NDA: 077567

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium TABLET, EXTENDED RELEASE;ORAL 077567 ANDA Mylan Pharmaceuticals Inc. 0378-0472 0378-0472-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-77)
DIVALPROEX SODIUM divalproex sodium TABLET, EXTENDED RELEASE;ORAL 077567 ANDA Mylan Pharmaceuticals Inc. 0378-0472 0378-0472-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Jan 29, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Jan 29, 2009TE:ABRLD:No


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