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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 201367


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NDA 201367 describes BANZEL, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the BANZEL profile page.

The generic ingredient in BANZEL is rufinamide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 201367
Tradename:BANZEL
Applicant:Eisai Inc
Ingredient:rufinamide
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BANZEL rufinamide SUSPENSION;ORAL 201367 NDA Eisai Inc. 62856-584 62856-584-46 1 BOTTLE in 1 CARTON (62856-584-46) > 460 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 201367
Tradename Dosage Ingredient NDA Submissiondate
BANZEL SUSPENSION;ORAL rufinamide 201367 2014-06-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Mar 3, 2011TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 14, 2023Product Flag?Substance Flag?Delist Request?Y

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