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 |
|---|
| 2023/02/23 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/07/20 |
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:EPTIFIBATIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/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 |
|---|
| 090854 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2015/06/12
|
TEVA PHARMS USA |
| 206127 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2015/12/08
|
EUGIA PHARMA |
| 204589 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
2017/04/18
|
RISING |
| 205557 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
2017/11/06
|
ACCORD HLTHCARE |
| 204693 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2018/03/07
|
SAGENT PHARMS INC |
| 203258 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
Yes |
AP |
2018/07/20
|
MYLAN LABS LTD |
| 208554 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
2018/11/23
|
BAXTER HLTHCARE CORP |
| 209864 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2019/01/25
|
SLATE RUN PHARMA |
| 213081 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2021/09/07
|
SHUANGCHENG |
| 213599 |
001 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2024/05/09
|
HONG KONG |
活性成分:EPTIFIBATIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:75MG/100ML 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 |
|---|
| 206127 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2015/12/08
|
EUGIA PHARMA |
| 204589 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Discontinued |
No |
No |
AP |
2017/04/18
|
RISING |
| 205557 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Discontinued |
No |
No |
AP |
2017/11/06
|
ACCORD HLTHCARE |
| 204693 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2018/03/07
|
SAGENT PHARMS INC |
| 203258 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
Yes |
AP |
2018/07/20
|
MYLAN LABS LTD |
| 208554 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2018/11/23
|
BAXTER HLTHCARE CORP |
| 209864 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2019/01/25
|
SLATE RUN PHARMA |
| 213081 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2022/04/20
|
SHUANGCHENG |
| 213599 |
002 |
ANDA |
EPTIFIBATIDE |
EPTIFIBATIDE |
INJECTABLE;INJECTION |
75MG/100ML |
Prescription |
No |
No |
AP |
2024/05/09
|
HONG KONG |