اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BANZEL از شرکت EISAI INC
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/0201367,021911s007lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/28/2019 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021911Orig1s017,201367Orig1s008ltr.pdf |
||
| 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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 11/28/2019 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021911s017,201367s008lbl.pdf | |
| 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 | 213410 | ALKEM LABS LTD |
| RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 211388 | BIONPHARMA INC |
| RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 207363 | HIKMA |
| RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213457 | LUPIN LTD |
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