Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021911
Company: EISAI INC
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BANZEL | RUFINAMIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
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-Package Insert, Labeling-Medication Guide, 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 |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021911Orig1s013, 201367Orig1s005lbl.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-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 |
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 |