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=NDA215211"
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
71904-300-01 71904-300 HUMAN PRESCRIPTION DRUG OPFOLDA miglustat CAPSULE ORAL 20231011 N/A NDA NDA215211 AMICUS THERAPEUTICS US, LLC MIGLUSTAT 65 mg/1 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC
71904-300-02 71904-300 HUMAN PRESCRIPTION DRUG OPFOLDA miglustat CAPSULE ORAL 20231011 N/A NDA NDA215211 AMICUS THERAPEUTICS US, LLC MIGLUSTAT 65 mg/1 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC
71904-300-03 71904-300 HUMAN PRESCRIPTION DRUG OPFOLDA miglustat CAPSULE ORAL 20231011 N/A NDA NDA215211 AMICUS THERAPEUTICS US, LLC MIGLUSTAT 65 mg/1 100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC
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