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Generated: December 12, 2018

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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 suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
Summary for 078734
Tradename:OXCARBAZEPINE
Applicant:Sun Pharm Inds Ltd
Ingredient:oxcarbazepine
Patents:0
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 63304-653-25 250 mL in 1 BOTTLE (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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