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=NDA207925"
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
51167-400-01 51167-400 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20150323 N/A NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 75 mg/1 56 GRANULE in 1 CARTON (51167-400-01)
51167-600-01 51167-600 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20190429 N/A NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 25 mg/1 56 GRANULE in 1 CARTON (51167-600-01)
51167-785-01 51167-785 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20230503 N/A NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 5.8 mg/1 56 GRANULE in 1 CARTON (51167-785-01)
51167-770-01 51167-770 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20230503 N/A NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 13.4 mg/1 56 GRANULE in 1 CARTON (51167-770-01)
51167-300-01 51167-300 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20150323 N/A NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 50 mg/1 56 GRANULE in 1 CARTON (51167-300-01)
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