药品名称ICLUSIG
申请号203469产品号001
活性成分PONATINIB HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 15MG BASE
治疗等效代码参比药物
批准日期2012/12/14申请机构ARIAD 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
90295332026/12/22U-1700PDF格式
90295332026/12/22U-836PDF格式
90295332026/12/22U-1701PDF格式
90295332026/12/22U-1283PDF格式
90295332026/12/22U-1699PDF格式
81148742026/12/22YYPDF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
NCE2017/12/14
ODE2019/12/14
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
203469024APLetter2016/09/08下载
203469024APLabel2016/09/12下载
203469023APLetter2016/09/02下载
203469023APLabel2016/09/02下载
203469021APLabel2016/06/06下载
203469021APLetter2016/06/06下载
203469020APLetter2015/12/03下载
203469020APLabel2015/12/08下载
203469009APLabel2014/07/28下载
203469009APLetter2014/07/28下载
203469008APReview2014/07/07下载
203469008APLabel2013/12/20下载
203469008APMedication Guide2013/12/20下载
203469008APLetter2013/12/20下载
203469007APLetter2013/12/20下载
203469007APReview2014/07/07下载
203469007APLabel2013/12/20下载
203469007APMedication Guide2013/12/20下载
203469000APOther2013/12/20下载
203469000APOther Important Information from FDA2014/02/04下载
203469000APLabel2012/12/14下载
203469000APMedication Guide2012/12/18下载
203469000APLetter2012/12/19下载
203469000APReview2012/12/21下载
203469000APSummary Review2012/12/21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
203469024AP2016/09/07Labeling Revision
203469023AP2016/08/31Labeling Revision
203469021AP2016/06/02Efficacy Supplement with Clinical Data to Support
203469020AP2015/12/02Labeling Revision
203469019AP2015/12/01Manufacturing Change or Addition
203469018AP2015/08/24Manufacturing Change or Addition
203469017AP2015/04/23Manufacturing Change or Addition
203469016AP2015/04/17Manufacturing Change or Addition
203469015AP2015/05/20Manufacturing Change or Addition
203469014AP2015/02/03Manufacturing Change or Addition
203469013AP2015/01/20Manufacturing Change or Addition
203469012AP2014/09/09Manufacturing Change or Addition
203469011AP2014/08/15Manufacturing Change or Addition
203469010AP2014/07/30Manufacturing Change or Addition
203469009AP2014/07/24Labeling Revision
203469008AP2013/12/20Labeling Revision
203469007AP2013/12/20Labeling Revision
203469006AP2014/03/27Manufacturing Change or Addition
203469004AP2014/01/30Manufacturing Change or Addition
203469003AP2013/08/12Manufacturing Change or Addition
203469002AP2013/06/25Manufacturing Change or Addition
203469000AP2012/12/14Approval