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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Federal Trade Commission
Queensland Health
QuintilesIMS
Covington
Moodys
Cipla
Johnson and Johnson
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077794

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NDA 077794 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 077794
Tradename:OXCARBAZEPINE
Applicant:Sun Pharm Inds
Ingredient:oxcarbazepine
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 077794
Suppliers and Packaging for NDA: 077794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6593 N 0615-6593-39
OXCARBAZEPINE oxcarbazepine TABLET;ORAL 077794 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6594 N 0615-6594-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 9, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 9, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Deloitte
QuintilesIMS
Express Scripts
Covington
McKesson
Queensland Health
Fish and Richardson

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