药品注册申请号:021759
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
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 ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Yes Yes AP 2005/01/31 2005/01/31 Prescription
002 ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Yes Yes AP 2005/01/31 Prescription
003 ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2006/11/17 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2020/04/06 SUPPL 23 Approval Labeling STANDARD
2016/12/09 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2015/10/01 SUPPL 19 Approval Labeling STANDARD
2015/01/20 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2013/11/15 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2013/07/16 SUPPL 16 Approval Labeling STANDARD
2012/10/12 SUPPL 15 Approval Labeling STANDARD
2011/12/28 SUPPL 12 Approval Labeling UNKNOWN
2009/07/22 SUPPL 10 Approval Manufacturing (CMC) N/A
2009/03/13 SUPPL 9 Approval Labeling STANDARD
2008/05/21 SUPPL 8 Approval Labeling STANDARD
2006/11/17 SUPPL 6 Approval Manufacturing (CMC) N/A
2006/03/09 SUPPL 1 Approval Labeling STANDARD
2005/01/31 ORIG 1 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
001 5290961 2013/01/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5290961*PED 2013/07/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5338874 2013/04/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5338874*PED 2013/10/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5420319 2016/08/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5420319*PED 2017/02/09 PDF格式**本条是由Drugfuture回溯的历史信息**
5716988 2015/08/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5716988*PED 2016/02/07 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5290961 2013/01/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5290961*PED 2013/07/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5338874 2013/04/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5338874*PED 2013/10/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5420319 2016/08/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5420319*PED 2017/02/09 PDF格式**本条是由Drugfuture回溯的历史信息**
5716988 2015/08/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5716988*PED 2016/02/07 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5290961 2013/01/12 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5290961*PED 2013/07/12 PDF格式**本条是由Drugfuture回溯的历史信息**
5338874 2013/04/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5338874*PED 2013/10/07 PDF格式**本条是由Drugfuture回溯的历史信息**
5420319 2016/08/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5420319*PED 2017/02/09 PDF格式**本条是由Drugfuture回溯的历史信息**
5716988 2015/08/07 Y PDF格式**本条是由Drugfuture回溯的历史信息**
5716988*PED 2016/02/07 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-441 2007/11/04**本条是由Drugfuture回溯的历史信息**
NCE 2007/08/09**本条是由Drugfuture回溯的历史信息**
PED 2008/02/09**本条是由Drugfuture回溯的历史信息**
PED 2008/05/04**本条是由Drugfuture回溯的历史信息**
002 I-441 2007/11/04**本条是由Drugfuture回溯的历史信息**
NCE 2007/08/09**本条是由Drugfuture回溯的历史信息**
PED 2008/02/09**本条是由Drugfuture回溯的历史信息**
PED 2008/05/04**本条是由Drugfuture回溯的历史信息**
003 I-441 2007/11/04**本条是由Drugfuture回溯的历史信息**
NCE 2007/08/09**本条是由Drugfuture回溯的历史信息**
PED 2008/02/09**本条是由Drugfuture回溯的历史信息**
PED 2008/05/04**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/10ML (5MG/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
021759 001 NDA ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription Yes Yes AP 2005/01/31 SANOFI AVENTIS US
022160 001 NDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription Yes Yes AP 2009/08/07 TEVA PHARMS
078813 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2009/08/07 HOSPIRA WORLDWIDE
078811 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2010/06/10 FRESENIUS KABI USA
078817 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2011/01/24 SANDOZ
091358 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2012/08/07 MYLAN LABS LTD
203869 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2014/06/18 JIANGSU HENGRUI MED
204368 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2016/06/07 QILU
090030 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/01/31 FRESENIUS KABI USA
207325 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/02/10 GLAND PHARMA LTD
208523 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/02/10 CIPLA
207474 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/03/21 ACCORD HLTHCARE
205529 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2017/09/06 EUGIA PHARMA
204880 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2018/03/05 ACTAVIS LLC
207562 001 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 50MG/10ML (5MG/ML) Prescription No No AP 2018/10/16 INGENUS PHARMS LLC
活性成分:OXALIPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:100MG/20ML (5MG/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
021759 002 NDA ELOXATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription Yes Yes AP 2005/01/31 SANOFI AVENTIS US
022160 002 NDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription Yes Yes AP 2009/08/07 TEVA PHARMS
078813 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2009/08/07 HOSPIRA WORLDWIDE
078811 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2010/06/10 FRESENIUS KABI USA
078817 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2011/01/24 SANDOZ
091358 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2012/08/07 MYLAN LABS LTD
203869 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2014/06/18 JIANGSU HENGRUI MED
204368 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2016/06/07 QILU
090030 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/01/31 FRESENIUS KABI USA
207325 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/02/10 GLAND PHARMA LTD
208523 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/02/10 CIPLA
207474 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/03/21 ACCORD HLTHCARE
205529 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2017/09/06 EUGIA PHARMA
204880 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2018/03/05 ACTAVIS LLC
207562 002 ANDA OXALIPLATIN OXALIPLATIN INJECTABLE;INTRAVENOUS 100MG/20ML (5MG/ML) Prescription No No AP 2018/10/16 INGENUS PHARMS LLC
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