美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA204781"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
67684-2000-2 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL
67684-2000-3 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL
67684-2000-5 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 5 SYRINGE in 1 PACKAGE (67684-2000-5) / 10 mL in 1 SYRINGE
67684-2000-6 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 5 SYRINGE in 1 PACKAGE (67684-2000-6) / 15 mL in 1 SYRINGE
67684-2000-7 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 5 SYRINGE in 1 PACKAGE (67684-2000-7) / 20 mL in 1 SYRINGE
67684-2001-4 67684-2001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130426 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 6 VIAL in 1 PACKAGE (67684-2001-4) / 100 mL in 1 VIAL
67684-2001-0 67684-2001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20191024 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2001-0) / 5 mL in 1 VIAL
67684-2001-1 67684-2001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20191024 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2001-1) / 10 mL in 1 VIAL
67684-2001-2 67684-2001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20191024 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL
67684-2001-3 67684-2001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20191024 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2001-3) / 20 mL in 1 VIAL
67684-3001-1 67684-3001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20190918 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) / 10 mL in 1 SYRINGE, PLASTIC
67684-3001-2 67684-3001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20190918 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-2) / 15 mL in 1 SYRINGE, PLASTIC
67684-3001-3 67684-3001 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20190918 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC
67684-2000-1 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL
67684-2000-0 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20170331 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL
67684-2000-4 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130426 N/A NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL 6 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL
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