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=ANDA216434"
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
68083-496-10 68083-496 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20220526 N/A ANDA ANDA216434 Gland Pharma Limited BUMETANIDE .25 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-496-10) / 4 mL in 1 VIAL, SINGLE-DOSE (68083-496-01)
68462-470-54 68462-470 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20230101 N/A ANDA ANDA216434 GLENMARK PHARMACEUTICALS INC., USA BUMETANIDE .25 mg/mL 10 VIAL, MULTI-DOSE in 1 CARTON (68462-470-54) / 10 mL in 1 VIAL, MULTI-DOSE (68462-470-40)
68462-469-54 68462-469 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20230101 N/A ANDA ANDA216434 GLENMARK PHARMACEUTICALS INC., USA BUMETANIDE .25 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-469-54) / 4 mL in 1 VIAL, SINGLE-DOSE (68462-469-40)
65219-572-10 65219-572 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20220926 N/A ANDA ANDA216434 Fresenius Kabi USA, LLC BUMETANIDE .25 mg/mL 10 VIAL, MULTI-DOSE in 1 CARTON (65219-572-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-572-01)
65219-570-04 65219-570 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20220926 N/A ANDA ANDA216434 Fresenius Kabi USA, LLC BUMETANIDE .25 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)
68083-497-10 68083-497 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20220526 N/A ANDA ANDA216434 Gland Pharma Limited BUMETANIDE .25 mg/mL 10 VIAL, MULTI-DOSE in 1 CARTON (68083-497-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-497-01)
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