药品注册申请号：201525
申请类型：NDA (新药申请)
申请人：SANDOZ
申请人全名：SANDOZ
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/2ML (10MG/ML) No No AP 2011/06/29 2011/06/29 Prescription
002 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 80MG/8ML (10MG/ML) No No AP 2011/06/29 Prescription
003 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 160MG/16ML (10MG/ML) No No AP 2011/06/29 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
2023/09/21 SUPPL-24（补充） Approval Labeling STANDARD
2021/01/13 SUPPL-22（补充） Approval Labeling STANDARD
2020/08/11 SUPPL-20（补充） Approval Labeling STANDARD
2020/01/06 SUPPL-19（补充） Approval Labeling STANDARD
2019/03/27 SUPPL-17（补充） Approval Labeling STANDARD
2019/03/27 SUPPL-16（补充） Approval Labeling STANDARD
2016/10/21 SUPPL-12（补充） Approval Labeling STANDARD
2016/07/25 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
2014/11/04 SUPPL-9（补充） Approval Labeling STANDARD
2014/11/04 SUPPL-8（补充） Approval Labeling STANDARD
2014/08/18 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
2014/04/23 SUPPL-3（补充） Approval Labeling STANDARD
2012/03/15 SUPPL-2（补充） Approval Labeling UNKNOWN
2011/06/29 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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/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RLDRSTE 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) Prescription 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 PHARMA LTD
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RLDRSTE 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) Prescription 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 PHARMA LTD
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RLDRSTE 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) Prescription 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 PHARMA LTD
215744 003 ANDA DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 160MG/16ML (10MG/ML) Prescription No No AP 2023/02/28 ALEMBIC
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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