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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Chinese Patent Office

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078005

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NDA 078005 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 twenty-three 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-seven suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 078005
Applicant:Ani Pharms Inc
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 11, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 11, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Dec 11, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Express Scripts

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