批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2023/06/07 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/19 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:RIZATRIPTAN BENZOATE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:EQ 5MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 078739 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
CHARTWELL RX |
| 201914 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
GLENMARK PHARMS LTD |
| 203062 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2013/07/01
|
AUROBINDO PHARMA LTD |
| 203478 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2013/07/01
|
NATCO PHARMA LTD |
| 203146 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2014/09/19
|
MACLEODS PHARMS LTD |
| 204722 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2017/01/11
|
PANACEA |
| 207835 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2017/03/07
|
UNICHEM |
活性成分:RIZATRIPTAN BENZOATE 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL 规格:EQ 10MG BASE 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 020865 |
002 |
NDA |
MAXALT-MLT |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Prescription |
Yes |
Yes |
AB |
1998/06/29
|
ORGANON |
| 078739 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
CHARTWELL RX |
| 201914 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
GLENMARK PHARMS LTD |
| 203062 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2013/07/01
|
AUROBINDO PHARMA LTD |
| 203478 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2013/07/01
|
NATCO PHARMA LTD |
| 203146 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2014/09/19
|
MACLEODS PHARMS LTD |
| 204722 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2017/01/11
|
PANACEA |
| 207835 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET, ORALLY DISINTEGRATING;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2017/03/07
|
UNICHEM |
