美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DOTAREM"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
DOTAREM 204781 001 NDA GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 37.69GM/100ML (376.9MG/ML) Yes Yes 2013/03/20 2013/03/20 GUERBET Prescription
DOTAREM 204781 002 NDA GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 3.769GM/10ML (376.9MG/ML) Yes Yes 2013/03/20 2013/03/20 GUERBET Prescription
DOTAREM 204781 003 NDA GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 5.6535GM/15ML (376.9MG/ML) Yes Yes 2013/03/20 2013/03/20 GUERBET Prescription
DOTAREM 204781 004 NDA GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 7.538GM/20ML (376.9MG/ML) Yes Yes 2013/03/20 2013/03/20 GUERBET Prescription
DOTAREM 204781 005 NDA GADOTERATE MEGLUMINE SOLUTION;INTRAVENOUS 1.8845GM/5ML (376.9MG/ML) Yes Yes 2013/03/20 2017/03/31 GUERBET Prescription
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