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 |
|---|
| 2023/01/10 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/12/03 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/12/03 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 2007/08/09 |
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:EPIRUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/25ML (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 |
|---|
| 050778 |
002 |
NDA |
ELLENCE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
Yes |
No |
AP |
1999/09/15
|
PFIZER INC |
| 065289 |
001 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/06/27
|
HIKMA |
| 065331 |
001 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/08/09
|
IMPAX LABS INC |
| 065361 |
001 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/10/22
|
CIPLA LTD |
| 065445 |
002 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Discontinued |
No |
No |
AP |
2008/09/18
|
ACTAVIS TOTOWA |
| 090163 |
001 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AP |
2009/06/24
|
EPIC PHARMA LLC |
| 090075 |
001 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/25ML (2MG/ML) |
Prescription |
No |
No |
AP |
2010/03/25
|
HISUN PHARM HANGZHOU |
活性成分:EPIRUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/100ML (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 |
|---|
| 050778 |
001 |
NDA |
ELLENCE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Prescription |
Yes |
Yes |
AP |
1999/09/15
|
PFIZER INC |
| 065289 |
002 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/06/27
|
HIKMA |
| 065331 |
002 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/08/09
|
IMPAX LABS INC |
| 065361 |
002 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2007/10/22
|
CIPLA LTD |
| 065445 |
003 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Discontinued |
No |
No |
AP |
2008/09/18
|
ACTAVIS TOTOWA |
| 090075 |
002 |
ANDA |
EPIRUBICIN HYDROCHLORIDE |
EPIRUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML (2MG/ML) |
Prescription |
No |
No |
AP |
2010/03/25
|
HISUN PHARM HANGZHOU |