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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078734

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NDA 078734 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 078734
Applicant:Sun Pharm Inds Ltd
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078734
Suppliers and Packaging for NDA: 078734
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 078734 ANDA Ranbaxy Pharmaceuticals Inc. 63304-653 N 63304-653-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:Jun 26, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Fish and Richardson

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