药品名称AMYVID
申请号202008产品号002
活性成分FLORBETAPIR F-18市场状态处方药
剂型或给药途径SOLUTION;INTRAVENOUS规格10-30ML (13.5-51mCi/ML)
治疗等效代码参比药物是
批准日期2012/04/06申请机构AVID RADIOPHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority review drug
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
85069292027/04/30YYU-1423PDF格式
76870522027/04/30YYPDF格式
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
NCE2017/04/06
历史市场独占权保护信息
无
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
202008020APLetter2013/12/16下载
202008020APLabel2013/12/17下载
202008000APLetter2012/04/06下载
202008000APLabel2012/04/09下载
202008000APReview2012/05/03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
202008027AP2016/08/31Manufacturing Change or Addition
202008026AP2016/06/22Manufacturing Change or Addition
202008025AP2016/03/09Manufacturing Change or Addition
202008024AP2015/07/09Manufacturing Change or Addition
202008023AP2015/06/25Manufacturing Change or Addition
202008022AP2015/07/09Manufacturing Change or Addition
202008021AP2014/03/14Manufacturing Change or Addition
202008020AP2013/12/12Labeling Revision
202008019AP2013/11/08Manufacturing Change or Addition
202008018AP2013/10/25Manufacturing Change or Addition
202008017AP2013/03/22Manufacturing Change or Addition
202008016AP2013/03/06Manufacturing Change or Addition
202008015AP2013/03/27Manufacturing Change or Addition
202008014AP2013/03/22Manufacturing Change or Addition
202008013AP2013/03/06Manufacturing Change or Addition
202008012AP2013/03/06Manufacturing Change or Addition
202008011AP2013/02/19Manufacturing Change or Addition
202008010AP2013/02/19Manufacturing Change or Addition
202008009AP2013/03/13Manufacturing Change or Addition
202008008AP2013/01/18Manufacturing Change or Addition
202008007AP2013/02/19Manufacturing Change or Addition
202008006AP2013/01/18Manufacturing Change or Addition
202008000AP2012/04/06Approval