药品注册申请号：209640
申请类型：ANDA (仿制药申请)
申请人：AMNEAL
申请人全名：AMNEAL EU LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 20MG/ML (20MG/ML) No No AP 2018/01/19 2018/01/19 Prescription
002 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 80MG/4ML (20MG/ML) No No AP 2018/01/19 Prescription
003 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 160MG/8ML (20MG/ML) No No AP 2018/01/19 Prescription
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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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RLDRSTE 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 HERITAGE
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RLDRSTE 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 HERITAGE
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RLDRSTE 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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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