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 |
|---|
| 2005/07/20 |
ORIG-1（原始申请） |
Approval |
|
|
|
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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:MILRINONE LACTATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 40MG BASE/200ML (EQ 0.2MG 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 |
|---|
| 075834 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2002/05/28
|
BAXTER HLTHCARE |
| 075885 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Discontinued |
No |
No |
AP |
2002/05/28
|
HOSPIRA |
| 077151 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
No |
AP |
2005/07/20
|
WOODWARD |
| 078113 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/05/21
|
WEST-WARD PHARMS INT |
| 090038 |
002 |
ANDA |
MILRINONE LACTATE IN PLASTIC CONTAINER |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
No |
AP |
2010/01/21
|
HIKMA FARMACEUTICA |
| 213585 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/07/16
|
GLAND PHARMA LTD |
| 209666 |
002 |
ANDA |
MILRINONE LACTATE IN DEXTROSE 5% |
MILRINONE LACTATE |
INJECTABLE;INJECTION |
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) |
Prescription |
No |
No |
AP |
2020/09/03
|
EUGIA PHARMA |