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. Ten suppliers are 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Mar 3, 2011	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	May 14, 2023	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 201367

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367-001	Mar 3, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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