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Citi
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Julphar
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Fish and Richardson
Federal Trade Commission
US Department of Justice
QuintilesIMS

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077801

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NDA 077801 describes OXCARBAZEPINE, which is a drug marketed by Amneal Pharms, Sun Pharm Inds Ltd, West-ward Pharms Int, Ani Pharms Inc, Apotex Inc, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, and Taro, and is included in eleven NDAs. It is available from eighteen suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 077801
Tradename:OXCARBAZEPINE
Applicant:Taro
Ingredient:oxcarbazepine
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077801
Suppliers and Packaging for NDA: 077801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077801 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4105 N 51672-4105-6
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077801 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4105 N 51672-4105-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Nov 15, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Nov 15, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Nov 15, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Federal Trade Commission
McKesson
Chubb
Cerilliant
Argus Health
QuintilesIMS
Medtronic
Covington

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