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 |
|---|
| 2020/01/22 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/01/22 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/05/19 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2016/02/18 |
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;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 |
|---|
| 079230 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
SANDOZ |
| 200482 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
NATCO PHARMA LTD |
| 201967 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
GLENMARK PHARMS LTD |
| 201993 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
MYLAN PHARMS INC |
| 202047 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
CREEKWOOD PHARMS |
| 202490 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
AUROBINDO PHARMA LTD |
| 077263 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
TEVA PHARMS |
| 077526 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2013/03/26
|
CHARTWELL RX |
| 204339 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
INVAGEN PHARMS |
| 203147 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2014/02/11
|
MACLEODS PHARMS LTD |
| 203269 |
001 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2016/02/18
|
ALKEM LABS LTD |
活性成分:RIZATRIPTAN BENZOATE 剂型/给药途径:TABLET;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 |
|---|
| 020864 |
002 |
NDA |
MAXALT |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
Yes |
Yes |
AB |
1998/06/29
|
ORGANON LLC |
| 077263 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
TEVA PHARMS |
| 079230 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
SANDOZ |
| 200482 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
NATCO PHARMA LTD |
| 201967 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2012/12/31
|
GLENMARK PHARMS LTD |
| 201993 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
MYLAN PHARMS INC |
| 202047 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
CREEKWOOD PHARMS |
| 202490 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2012/12/31
|
AUROBINDO PHARMA LTD |
| 077526 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2013/03/26
|
CHARTWELL RX |
| 204339 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2013/07/01
|
INVAGEN PHARMS |
| 203147 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2014/02/11
|
MACLEODS PHARMS LTD |
| 203269 |
002 |
ANDA |
RIZATRIPTAN BENZOATE |
RIZATRIPTAN BENZOATE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2016/02/18
|
ALKEM LABS LTD |