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 |
|---|
| 2024/05/23 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/25 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/08/25 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/09/11 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/04/23 |
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:SUMATRIPTAN SUCCINATE 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) 治疗等效代码:AP
| 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 |
|---|
| 078593 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/02/06
|
WOCKHARDT |
| 079123 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/02/06
|
WEST-WARD PHARMS INT |
| 079242 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/03/02
|
FRESENIUS KABI USA |
| 077332 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Discontinued |
No |
No |
AP |
2009/10/09
|
ENDO OPERATIONS |
| 202758 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2013/04/23
|
EUGIA PHARMA |
| 200183 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2013/09/16
|
HIKMA |
| 213998 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2021/07/13
|
CAPLIN |
| 207101 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Discontinued |
No |
No |
AP |
2023/01/19
|
BAXTER HLTHCARE CORP |
| 215651 |
001 |
ANDA |
SUMATRIPTAN SUCCINATE |
SUMATRIPTAN SUCCINATE |
INJECTABLE;SUBCUTANEOUS |
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) |
Prescription |
No |
No |
AP |
2024/11/21
|
STERISCIENCE SPECLTS |