药品名称KALYDECO
申请号203188产品号001
活性成分IVACAFTOR市场状态处方药
剂型或给药途径TABLET;ORAL规格150MG
治疗等效代码参比药物
批准日期2012/01/31申请机构VERTEX PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
83544272026/07/06U-1311PDF格式
83544272026/07/06U-1905PDF格式
83242422027/08/05U-1311PDF格式
83242422027/08/05U-1906PDF格式
87542242026/12/28YYPDF格式
84102742026/12/28YPDF格式
74951032027/05/20YYPDF格式
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
NCE2017/01/31
ODE2019/01/31
I-7052017/12/30
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
203188017APLetter2015/03/06下载
203188017APLabel2015/03/20下载
203188015APLabel2015/01/09下载
203188015APLetter2015/01/06下载
203188014APLabel2015/01/09下载
203188014APLetter2015/01/06下载
203188008APLetter2014/04/10下载
203188008APLabel2014/04/10下载
203188007APLabel2014/06/17下载
203188007APLetter2014/06/18下载
203188004APLetter2014/02/25下载
203188004APLabel2014/02/25下载
203188001APLabel2012/08/29下载
203188001APLetter2012/08/29下载
203188000APOther Important Information from FDA2012/10/12下载
203188000APLabel2012/01/31下载
203188000APLetter2012/01/31下载
203188000APReview2012/03/13下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
203188021AP2016/08/31Manufacturing Change or Addition
203188020AP2016/05/20Manufacturing Change or Addition
203188018AP2015/09/01Manufacturing Change or Addition
203188017AP2015/03/04Labeling Revision
203188016AP2015/01/05Manufacturing Change or Addition
203188015AP2014/12/29Labeling Revision
203188014AP2014/12/29Efficacy Supplement with Clinical Data to Support
203188013AP2014/12/11Manufacturing Change or Addition
203188012AP2014/11/10Manufacturing Change or Addition
203188011AP2014/07/29Manufacturing Change or Addition
203188010AP2015/03/09Manufacturing Change or Addition
203188009AP2015/11/24Manufacturing Change or Addition
203188008AP2014/04/08Labeling Revision
203188007AP2014/06/13Labeling Revision
203188004AP2014/02/21Efficacy Supplement with Clinical Data to Support
203188003AP2013/12/13Manufacturing Change or Addition
203188002AP2013/06/03Manufacturing Change or Addition
203188001AP2012/08/28Labeling Revision
203188000AP2012/01/31Approval