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 |
2024/08/28 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/08/28 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/07/21 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/07/21 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/11 |
ORIG-1(原始申请) |
Approval |
|
STANDARD
|
|
|
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 PHARMA LTD |