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=ANDA214926"
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
68083-460-25 68083-460 HUMAN PRESCRIPTION DRUG Fosphenytoin sodium Fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20231013 N/A ANDA ANDA214926 Gland Pharma Limited FOSPHENYTOIN SODIUM 50 mg/mL 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)
68083-461-10 68083-461 HUMAN PRESCRIPTION DRUG Fosphenytoin sodium Fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20231013 N/A ANDA ANDA214926 Gland Pharma Limited FOSPHENYTOIN SODIUM 50 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)
68462-622-10 68462-622 HUMAN PRESCRIPTION DRUG Fosphenytoin sodium Fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20231013 N/A ANDA ANDA214926 GLENMARK PHARMACEUTICALS INC., USA FOSPHENYTOIN SODIUM 50 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-622-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-622-64)
68462-621-02 68462-621 HUMAN PRESCRIPTION DRUG Fosphenytoin sodium Fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20231013 N/A ANDA ANDA214926 GLENMARK PHARMACEUTICALS INC., USA FOSPHENYTOIN SODIUM 50 mg/mL 25 VIAL, SINGLE-DOSE in 1 CARTON (68462-621-02) / 2 mL in 1 VIAL, SINGLE-DOSE (68462-621-54)
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