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Serving 500+ biopharmaceutical companies globally:

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Harvard Business School
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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078790

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NDA 078790 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 Labs, Lupin, Sandoz, Impax Labs, and Sun Pharm Inds, 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 NDA: 078790

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

Pharmacology for NDA: 078790

Suppliers and Packaging for NDA: 078790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 078790 ANDA Rebel Distributors Corp 21695-817 21695-817-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-817-60)
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 078790 ANDA Rebel Distributors Corp 21695-818 21695-818-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-818-60)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
US Department of Justice
AstraZeneca
Boehringer Ingelheim
Julphar
Colorcon
Federal Trade Commission
Merck
McKinsey

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