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Baxter
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Dow
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McKesson
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078597

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NDA 078597 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 thirty-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. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078597
Tradename:DIVALPROEX SODIUM
Applicant:Sun Pharm Inds
Ingredient:divalproex sodium
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078597
Suppliers and Packaging for NDA: 078597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078597 ANDA Aidarex Pharmaceuticals LLC 33261-641 N 33261-641-90
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078597 ANDA Aidarex Pharmaceuticals LLC 33261-641 N 33261-641-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Queensland Health

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