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=ANDA218073"
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
70436-123-34 70436-123 HUMAN PRESCRIPTION DRUG gadoterate meglumine gadoterate meglumine INJECTION INTRAVENOUS 20240601 N/A ANDA ANDA218073 Slate Run Pharmaceuticals, LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 CARTON (70436-123-34) / 15 mL in 1 VIAL
70436-123-35 70436-123 HUMAN PRESCRIPTION DRUG gadoterate meglumine gadoterate meglumine INJECTION INTRAVENOUS 20240601 N/A ANDA ANDA218073 Slate Run Pharmaceuticals, LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 CARTON (70436-123-35) / 20 mL in 1 VIAL
70436-123-80 70436-123 HUMAN PRESCRIPTION DRUG gadoterate meglumine gadoterate meglumine INJECTION INTRAVENOUS 20240628 N/A ANDA ANDA218073 Slate Run Pharmaceuticals, LLC GADOTERATE MEGLUMINE 376.9 mg/mL 1 VIAL in 1 CARTON (70436-123-80) / 100 mL in 1 VIAL (70436-123-40)
70436-123-33 70436-123 HUMAN PRESCRIPTION DRUG gadoterate meglumine gadoterate meglumine INJECTION INTRAVENOUS 20240601 N/A ANDA ANDA218073 Slate Run Pharmaceuticals, LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL
70436-123-31 70436-123 HUMAN PRESCRIPTION DRUG gadoterate meglumine gadoterate meglumine INJECTION INTRAVENOUS 20240601 N/A ANDA ANDA218073 Slate Run Pharmaceuticals, LLC GADOTERATE MEGLUMINE 376.9 mg/mL 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
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