Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021911
Company: EISAI INC
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BANZEL RUFINAMIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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
06/17/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/25/2015 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/25/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf
06/25/2015 SUPPL-13 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.pdf
06/25/2015 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s013,201367s005lbl.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

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 205075 GLENMARK PHARMS LTD
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 205095 MYLAN PHARMS INC
RUFINAMIDE RUFINAMIDE 200MG TABLET;ORAL Prescription No AB 204988 WEST-WARD PHARMS INT

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 205075 GLENMARK PHARMS LTD
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 205095 MYLAN PHARMS INC
RUFINAMIDE RUFINAMIDE 400MG TABLET;ORAL Prescription No AB 204988 WEST-WARD PHARMS INT

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