药品注册申请号:204781
申请类型:NDA (新药申请)
申请人:GUERBET
申请人全名:GUERBET 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 DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 37.69GM/100ML (376.9MG/ML) Yes Yes None 2013/03/20 2013/03/20 Prescription
002 DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) Yes Yes AP 2013/03/20 Prescription
003 DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) Yes Yes AP 2013/03/20 Prescription
004 DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) Yes Yes AP 2013/03/20 Prescription
005 DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 1.8845GM/5ML (376.9MG/ML) Yes Yes None 2017/03/31 Prescription
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
2019/07/23 SUPPL 12 Approval Labeling STANDARD
2018/11/02 SUPPL 9 Approval Labeling STANDARD
2018/04/26 SUPPL 8 Approval Labeling STANDARD
2017/09/14 SUPPL 5 Approval Labeling STANDARD
2017/08/25 SUPPL 1 Approval Efficacy STANDARD
2017/03/31 SUPPL 2 Approval Manufacturing (CMC) N/A
2013/03/20 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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
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 NPP 2020/08/25
002 NPP 2020/08/25
003 NPP 2020/08/25
004 NPP 2020/08/25
005 NPP 2020/08/25
001 NCE 2018/03/20**本条是由Drugfuture回溯的历史信息**
002 NCE 2018/03/20**本条是由Drugfuture回溯的历史信息**
003 NCE 2018/03/20**本条是由Drugfuture回溯的历史信息**
004 NCE 2018/03/20**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:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:3.769GM/10ML (376.9MG/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
204781 002 NDA DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) Prescription Yes Yes AP 2013/03/20 GUERBET
210016 001 ANDA CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) Prescription No No AP 2019/11/01 GE HEALTHCARE
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:5.6535GM/15ML (376.9MG/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
204781 003 NDA DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) Prescription Yes Yes AP 2013/03/20 GUERBET
210016 002 ANDA CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) Prescription No No AP 2019/11/01 GE HEALTHCARE
活性成分:GADOTERATE MEGLUMINE 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:7.538GM/20ML (376.9MG/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
204781 004 NDA DOTAREM GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) Prescription Yes Yes AP 2013/03/20 GUERBET
210016 003 ANDA CLARISCAN GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) Prescription No No AP 2019/11/01 GE HEALTHCARE
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