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Citi
Boehringer Ingelheim
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Cantor Fitzgerald
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201193

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NDA 201193 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-two 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-six suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 201193

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 201193

Suppliers and Packaging for NDA: 201193

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXCARBAZEPINE oxcarbazepine SUSPENSION;ORAL 201193 ANDA West-Ward Pharmaceuticals Corp. 0054-0199 0054-0199-59 250 mL in 1 BOTTLE (0054-0199-59)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength300MG/5ML
Approval Date:Oct 3, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Federal Trade Commission
Fish and Richardson
Teva
Queensland Health
Covington
Moodys
Medtronic
US Department of Justice

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