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=NDA213004"
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
57841-1150-4 57841-1150 HUMAN PRESCRIPTION DRUG Talicia omeprazole magnesium, amoxicillin and rifabutin CAPSULE, DELAYED RELEASE ORAL 20210924 N/A NDA NDA213004 RedHill Biopharma Ltd AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN 250 mg/1; 10 mg/1; 12.5 mg/1 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)
57841-1150-2 57841-1150 HUMAN PRESCRIPTION DRUG Talicia omeprazole magnesium, amoxicillin and rifabutin CAPSULE, DELAYED RELEASE ORAL 20200309 N/A NDA NDA213004 RedHill Biopharma Ltd AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN 250 mg/1; 10 mg/1; 12.5 mg/1 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)
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