Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201367
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BANZEL RUFINAMIDE 40MG/ML SUSPENSION;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
03/03/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367_banzel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201367Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/25/2015 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide 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-3 Efficacy-Labeling Change With Clinical Data 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
01/05/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/10/2011 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021911s008,201367s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/25/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
06/25/2015 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
06/25/2015 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.pdf
02/12/2015 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911s012lbl.pdf
03/03/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf

BANZEL

SUSPENSION;ORAL; 40MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BANZEL RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription Yes AB 201367 EISAI INC
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 211388 BIONPHARMA INC
RUFINAMIDE RUFINAMIDE 40MG/ML SUSPENSION;ORAL Prescription No AB 207363 HIKMA

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