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=NDA211358"
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
51167-122-01 51167-122 HUMAN PRESCRIPTION DRUG ORKAMBI lumacaftor and ivacaftor GRANULE ORAL 20220902 N/A NDA NDA211358 Vertex Pharmaceuticals Incorporated IVACAFTOR; LUMACAFTOR 94 mg/1; 75 mg/1 56 PACKET in 1 CARTON (51167-122-01) / 1 GRANULE in 1 PACKET
51167-500-02 51167-500 HUMAN PRESCRIPTION DRUG ORKAMBI lumacaftor and ivacaftor GRANULE ORAL 20180807 N/A NDA NDA211358 Vertex Pharmaceuticals Incorporated IVACAFTOR; LUMACAFTOR 188 mg/1; 150 mg/1 56 PACKET in 1 CARTON (51167-500-02) / 1 GRANULE in 1 PACKET
51167-900-01 51167-900 HUMAN PRESCRIPTION DRUG ORKAMBI lumacaftor and ivacaftor GRANULE ORAL 20180807 N/A NDA NDA211358 Vertex Pharmaceuticals Incorporated IVACAFTOR; LUMACAFTOR 125 mg/1; 100 mg/1 56 PACKET in 1 CARTON (51167-900-01) / 1 GRANULE in 1 PACKET
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