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 |
2018/01/19 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2012/07/25 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/11/18 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
2007/02/15 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
2003/07/28 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
2000/09/19 |
SUPPL-14(补充) |
Approval |
Labeling |
|
|
|
1999/08/24 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1998/12/01 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1997/04/30 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1996/10/31 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/07/29 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1995/02/24 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/02/24 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1993/11/16 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/07/28 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1993/05/27 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/06/08 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/02/03 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/10/05 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/03/17 |
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:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/VIAL 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 |
062921 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
Yes |
AP |
1989/03/17
|
HIKMA |
063097 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Discontinued |
No |
No |
AP |
1990/05/21
|
PHARMACHEMIE BV |
208888 |
001 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
20MG/VIAL |
Prescription |
No |
No |
AP |
2017/02/17
|
AMNEAL |
活性成分:DOXORUBICIN HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/VIAL 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 |
062921 |
003 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/VIAL |
Prescription |
No |
Yes |
AP |
1989/03/17
|
HIKMA |
063097 |
003 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/VIAL |
Discontinued |
No |
No |
AP |
1990/05/21
|
PHARMACHEMIE BV |
200170 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/VIAL |
Prescription |
No |
No |
AP |
2011/10/28
|
MYLAN LABS LTD |
208888 |
002 |
ANDA |
DOXORUBICIN HYDROCHLORIDE |
DOXORUBICIN HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/VIAL |
Prescription |
No |
No |
AP |
2017/02/17
|
AMNEAL |