Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | BANZEL | RUFINAMIDE |
| 002 | TABLET;ORAL | 200MG | 1 | BANZEL | RUFINAMIDE |
| 003 | TABLET;ORAL | 400MG | 1 | BANZEL | RUFINAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2008-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2009-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-11-08 | STANDARD |
| REMS; REMS | SUPPL | 7 | AP | 2011-03-03 | N/A |
| REMS; REMS | SUPPL | 8 | AP | 2011-06-10 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2013-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2015-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2016-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2019-11-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 8 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 17 | Null | 7 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
EISAI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21911
[companyName] => EISAI INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021911s017,201367s008lbl.pdf#page=19"]
[products] => [{"drugName":"BANZEL","activeIngredients":"RUFINAMIDE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BANZEL","activeIngredients":"RUFINAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"BANZEL","activeIngredients":"RUFINAMIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/28\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021911s017,201367s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"02\/12\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021911s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2011","submission":"SUPPL-7","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/0201367,021911s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2010","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021911s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021911lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BANZEL","submission":"RUFINAMIDE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BANZEL","submission":"RUFINAMIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"BANZEL","submission":"RUFINAMIDE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-11-28
)
)