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 |
|---|
| 1995/02/28 |
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 |
|---|
| 2002/09/19 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2000/08/25 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 2000/08/25 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2000/03/30 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/07/13 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1996/04/03 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1995/11/01 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:DOXORUBICIN HYDROCHLORIDE; 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 |
|---|
| 050629 |
001 |
NDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
Yes |
Yes |
AP |
1987/12/23
|
PFIZER |
| 062975 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
1989/03/17
|
HIKMA |
| 063336 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
1995/02/28
|
PHARMACHEMIE BV |
| 064140 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Discontinued |
No |
No |
AP |
1995/07/28
|
TEVA PHARMS USA |
| 063277 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
1995/10/26
|
FRESENIUS KABI USA |
| 091418 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2012/02/15
|
SUN PHARM INDS |
| 091495 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2013/03/18
|
SAGENT PHARMS |
| 203622 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2014/06/27
|
ACTAVIS INC |
| 209825 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2017/08/11
|
GLAND |
>>>活性成分:DOXORUBICIN HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:200MG/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 |
|---|
| 050629 |
002 |
NDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML |
Prescription |
Yes |
Yes |
AP |
1988/05/03
|
PFIZER |
| 064097 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML |
Prescription |
No |
No |
AP |
1994/09/13
|
HIKMA |
| 063336 |
004 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML |
Discontinued |
No |
No |
AP |
1995/02/28
|
PHARMACHEMIE BV |
| 064140 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML |
Discontinued |
No |
No |
AP |
1995/07/28
|
TEVA PHARMS USA |
| 203622 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/100ML |
Prescription |
No |
No |
AP |
2014/06/27
|
ACTAVIS INC |