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=ANDA215061"
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
65219-281-15 65219-281 HUMAN PRESCRIPTION DRUG Gadobutrol Gadobutrol INJECTION INTRAVENOUS 20230414 N/A ANDA ANDA215061 Fresenius Kabi USA, LLC GADOBUTROL 604.72 mg/mL 2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05)
65219-281-10 65219-281 HUMAN PRESCRIPTION DRUG Gadobutrol Gadobutrol INJECTION INTRAVENOUS 20230414 N/A ANDA ANDA215061 Fresenius Kabi USA, LLC GADOBUTROL 604.72 mg/mL 2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08)
65219-281-07 65219-281 HUMAN PRESCRIPTION DRUG Gadobutrol Gadobutrol INJECTION INTRAVENOUS 20230414 N/A ANDA ANDA215061 Fresenius Kabi USA, LLC GADOBUTROL 604.72 mg/mL 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03)
65219-281-02 65219-281 HUMAN PRESCRIPTION DRUG Gadobutrol Gadobutrol INJECTION INTRAVENOUS 20230414 N/A ANDA ANDA215061 Fresenius Kabi USA, LLC GADOBUTROL 604.72 mg/mL 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00)
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