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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078411

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NDA 078411 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: 078411

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

Pharmacology for NDA: 078411

Physiological EffectDecreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 078411

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM
divalproex sodium
 TABLET, DELAYED RELEASE;ORAL 078411 ANDA TWi Pharmaceuticals, Inc. 24979-514 24979-514-10 100 TABLET, DELAYED RELEASE in 1 BOTTLE (24979-514-10)
DIVALPROEX SODIUM
divalproex sodium
 TABLET, DELAYED RELEASE;ORAL 078411 ANDA TWi Pharmaceuticals, Inc. 24979-514 24979-514-50 500 TABLET, DELAYED RELEASE in 1 BOTTLE (24979-514-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Nov 3, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Citi
Cantor Fitzgerald
Farmers Insurance
QuintilesIMS
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Queensland Health
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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