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 |
|---|
| 2018/08/24 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 2023/09/15 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2019/12/13 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2019/03/13 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
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/2ML (10MG/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 |
|---|
| 022234 |
001 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/03/08
|
HOSPIRA INC |
| 201525 |
001 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
No |
No |
AP |
2011/06/29
|
SANDOZ |
| 210072 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/07/02
|
MYLAN LABS LTD |
| 209634 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/08/24
|
MEITHEAL |
| 214575 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Discontinued |
No |
No |
AP |
2021/06/25
|
EUGIA PHARMA |
| 213510 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
No |
No |
AP |
2021/07/01
|
GLAND |
| 215744 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
20MG/2ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/02/28
|
ALEMBIC |
>>>活性成分:DOCETAXEL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:80MG/8ML (10MG/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 |
|---|
| 022234 |
002 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/03/08
|
HOSPIRA INC |
| 201525 |
002 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2011/06/29
|
SANDOZ |
| 207563 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2017/08/31
|
NOVAST LABS |
| 210848 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/07/06
|
MYLAN LABS LTD |
| 209634 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/08/24
|
MEITHEAL |
| 214575 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Discontinued |
No |
No |
AP |
2021/06/25
|
EUGIA PHARMA |
| 213510 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2021/07/01
|
GLAND |
| 215744 |
002 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
80MG/8ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/02/28
|
ALEMBIC |
>>>活性成分:DOCETAXEL; 剂型/给药途径:INJECTABLE;INJECTION; 规格:160MG/16ML (10MG/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 |
|---|
| 022234 |
003 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/03/08
|
HOSPIRA INC |
| 201525 |
003 |
NDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2011/06/29
|
SANDOZ |
| 207563 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2017/08/31
|
NOVAST LABS |
| 208859 |
001 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/04/30
|
MYLAN LABS LTD |
| 209634 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2018/08/24
|
MEITHEAL |
| 214575 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Discontinued |
No |
No |
AP |
2021/06/25
|
EUGIA PHARMA |
| 213510 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2021/07/01
|
GLAND |
| 215744 |
003 |
ANDA |
DOCETAXEL |
DOCETAXEL |
INJECTABLE;INJECTION |
160MG/16ML (10MG/ML) |
Prescription |
No |
No |
AP |
2023/02/28
|
ALEMBIC |