Details for New Drug Application (NDA): 021911

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NDA 021911 describes BANZEL, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from two suppliers. 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. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.

Summary for 021911

Tradename:	BANZEL
Applicant:	Eisai Inc
Ingredient:	rufinamide
Patents:	0

Suppliers and Packaging for NDA: 021911

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BANZEL	rufinamide	TABLET;ORAL	021911	NDA	Eisai Inc.	62856-582	62856-582-04	4 TABLET, FILM COATED in 1 BOTTLE (62856-582-04)
BANZEL	rufinamide	TABLET;ORAL	021911	NDA	Eisai Inc.	62856-582	62856-582-52	120 TABLET, FILM COATED in 1 BOTTLE (62856-582-52)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 14, 2008	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Nov 14, 2008	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Nov 14, 2008	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021911

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-001	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-002	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
Eisai Inc	BANZEL	rufinamide	TABLET;ORAL	021911-003	Nov 14, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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