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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Healthtrust
Queensland Health
AstraZeneca
Express Scripts
Fuji
US Army
US Department of Justice
Mallinckrodt

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202961

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NDA 202961 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 202961
Tradename:OXCARBAZEPINE
Applicant:Amneal Pharms
Ingredient:oxcarbazepine
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 202961
Suppliers and Packaging for NDA: 202961
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 202961 ANDA Amneal Pharmaceuticals LLC 65162-649 N 65162-649-78
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 202961 ANDA Precision Dose, Inc. 68094-123 N 68094-123-62

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:Sep 17, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Queensland Health
Cerilliant
Chubb
UBS
US Department of Justice
Julphar
Healthtrust

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