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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2007/05/15 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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:IDARUBICIN HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:5MG/5ML (1MG/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 |
|---|
| 050734 |
001 |
NDA |
IDAMYCIN PFS |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/5ML (1MG/ML) |
Prescription |
Yes |
Yes |
AP |
1997/02/17
|
PFIZER |
| 065036 |
001 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/5ML (1MG/ML) |
Prescription |
No |
No |
AP |
2002/05/01
|
MEITHEAL |
| 065275 |
001 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/5ML (1MG/ML) |
Prescription |
No |
No |
AP |
2006/12/14
|
HIKMA |
| 065288 |
001 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
5MG/5ML (1MG/ML) |
Prescription |
No |
No |
AP |
2007/05/15
|
HIKMA |
>>>活性成分:IDARUBICIN HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:10MG/10ML (1MG/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 |
|---|
| 050734 |
002 |
NDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/10ML (1MG/ML) |
Prescription |
Yes |
Yes |
AP |
1997/02/17
|
PFIZER |
| 065036 |
002 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/10ML (1MG/ML) |
Prescription |
No |
No |
AP |
2002/05/01
|
MEITHEAL |
| 065275 |
002 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/10ML (1MG/ML) |
Prescription |
No |
No |
AP |
2006/12/14
|
HIKMA |
| 065288 |
002 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
10MG/10ML (1MG/ML) |
Prescription |
No |
No |
AP |
2007/05/15
|
HIKMA |
>>>活性成分:IDARUBICIN HYDROCHLORIDE; 剂型/给药途径:SOLUTION;INTRAVENOUS; 规格:20MG/20ML (1MG/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 |
|---|
| 050734 |
003 |
NDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
20MG/20ML (1MG/ML) |
Prescription |
Yes |
Yes |
AP |
1997/02/17
|
PFIZER |
| 065036 |
003 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
20MG/20ML (1MG/ML) |
Prescription |
No |
No |
AP |
2002/05/01
|
MEITHEAL |
| 065275 |
003 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
20MG/20ML (1MG/ML) |
Prescription |
No |
No |
AP |
2006/12/14
|
HIKMA |
| 065288 |
003 |
ANDA |
IDARUBICIN HYDROCHLORIDE |
IDARUBICIN HYDROCHLORIDE |
SOLUTION;INTRAVENOUS |
20MG/20ML (1MG/ML) |
Prescription |
No |
No |
AP |
2007/05/15
|
HIKMA |