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=ANDA090189"
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
63323-562-15 63323-562 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171030 N/A ANDA ANDA090189 Fresenius Kabi USA, LLC BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)
63323-562-10 63323-562 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161028 N/A ANDA ANDA090189 Fresenius Kabi USA, LLC BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
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