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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021911
Company: EISAI INC

Medication Guide

Summary Review

Products on NDA 021911

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BANZEL	RUFINAMIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
BANZEL	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	AB	Yes	No
BANZEL	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021911

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021911s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021911s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021911Orig1s017,201367Orig1s008ltr.pdf
06/17/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/25/2015	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s013,201367Orig1s005ltr.pdf
02/12/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021911Orig1s012,201367Orig1s003ltr.pdf
06/06/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/10/2011	SUPPL-8	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf
03/03/2011	SUPPL-7	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201367s000,021911s007ltr.pdf
11/08/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021911s005ltr.pdf
10/16/2009	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021911s004ltr.pdf

Labels for NDA 021911

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/28/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf
06/25/2015	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
06/25/2015	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
06/25/2015	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
02/12/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf
03/03/2011	SUPPL-7	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf
11/08/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021911s005lbl.pdf
11/14/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021911lbl.pdf

Therapeutic Equivalents for NDA 021911

BANZEL

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BANZEL	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	Yes	AB	021911	EISAI INC
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	217230	AUROBINDO PHARMA
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	205075	GLENMARK PHARMS LTD
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204993	HETERO LABS LTD III
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204988	HIKMA
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204964	LUPIN LTD
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	216688	MICRO LABS
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	205095	MYLAN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BANZEL	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	Yes	AB	021911	EISAI INC
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	217230	AUROBINDO PHARMA
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	205075	GLENMARK PHARMS LTD
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204993	HETERO LABS LTD III
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204988	HIKMA
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204964	LUPIN LTD
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	216688	MICRO LABS
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	205095	MYLAN

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