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 |
2023/09/19 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/09/19 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/09/19 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/09/19 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/09/19 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/19 |
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:DOCETAXEL 剂型/给药途径:INJECTABLE;INJECTION 规格:20MG/ML (20MG/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 |
020449 |
003 |
NDA |
TAXOTERE |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2010/08/03
|
SANOFI AVENTIS US |
201195 |
003 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
Yes |
No |
AP |
2012/04/20
|
ACCORD HLTHCARE |
203551 |
001 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2013/04/12
|
ACTAVIS |
204193 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2014/11/05
|
DR REDDYS |
205934 |
001 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2015/12/22
|
SHILPA |
207252 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2017/08/09
|
HENGRUI PHARMA |
209640 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2018/01/19
|
AMNEAL |
022534 |
003 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/01/08
|
SUN PHARM |
210327 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/05/16
|
SHILPA |
204490 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2021/01/14
|
HIKMA |
203892 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Discontinued |
No |
No |
AP |
2023/05/11
|
NORVIUM BIOSCIENCE |
216677 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/ML (20MG/ML) |
Prescription |
No |
No |
AP |
2024/02/28
|
ACIC PHARMS |
活性成分:DOCETAXEL 剂型/给药途径:INJECTABLE;INJECTION 规格:80MG/4ML (20MG/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 |
020449 |
004 |
NDA |
TAXOTERE |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2010/08/02
|
SANOFI AVENTIS US |
201195 |
004 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
Yes |
No |
AP |
2012/04/20
|
ACCORD HLTHCARE |
203551 |
002 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2013/04/12
|
ACTAVIS |
204193 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2014/11/05
|
DR REDDYS |
205934 |
002 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2015/12/22
|
SHILPA |
207252 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2017/08/09
|
HENGRUI PHARMA |
209640 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2018/01/19
|
AMNEAL |
022534 |
004 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/01/08
|
SUN PHARM |
210327 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/05/16
|
SHILPA |
204490 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2021/01/14
|
HIKMA |
203892 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Discontinued |
No |
No |
AP |
2023/05/11
|
NORVIUM BIOSCIENCE |
216677 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/4ML (20MG/ML) |
Prescription |
No |
No |
AP |
2024/02/28
|
ACIC PHARMS |
活性成分:DOCETAXEL 剂型/给药途径:INJECTABLE;INJECTION 规格:160MG/8ML (20MG/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 |
020449 |
005 |
NDA |
TAXOTERE |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2012/04/13
|
SANOFI AVENTIS US |
201195 |
005 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2012/04/20
|
ACCORD HLTHCARE |
203551 |
004 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2015/09/21
|
ACTAVIS |
205934 |
003 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
Yes |
Yes |
AP |
2015/12/22
|
SHILPA |
207252 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2017/08/09
|
HENGRUI PHARMA |
209640 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2018/01/19
|
AMNEAL |
022534 |
005 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/01/08
|
SUN PHARM |
208137 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/04/01
|
MYLAN LABS LTD |
210327 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/8ML (20MG/ML) |
Prescription |
No |
No |
AP |
2019/05/16
|
SHILPA |