药品名称ULTRAVIST 300
申请号020220产品号002
活性成分IOPROMIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格62.3%
治疗等效代码参比药物
批准日期1995/05/10申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Standard 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
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
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
020220041APLabel2015/07/09下载
020220041APLetter2015/07/10下载
020220036APLetter2012/05/04下载
020220036APLabel2012/05/07下载
020220035APLetter2010/01/20下载
020220033APLetter2010/01/05下载
020220033APLabel2010/01/08下载
020220027APLabel2007/09/04下载
020220027APLetter2007/09/06下载
020220022APLetter2005/08/15下载
020220018APLetter2004/03/16下载
020220018APLabel2004/04/05下载
020220008APLetter2003/05/29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
020220041AP2015/07/06Labeling Revision
020220040AP2013/07/29Manufacturing Change or Addition
020220036AP2012/05/02Labeling Revision
020220035AP2009/11/13Manufacturing Change or Addition
020220033AP2009/12/30New or Modified Indication
020220027AP2007/08/31Labeling Revision
020220022AP2005/08/12Labeling Revision
020220018AP2004/03/12Package Change
020220014AP2002/10/30Manufacturing Change or Addition
020220013AP2002/04/11Manufacturing Change or Addition
020220012AP2001/11/05Manufacturing Change or Addition
020220011AP2001/01/04Package Change
020220010AP2000/10/24Manufacturing Change or Addition
020220009AP2000/09/27Control Supplement
020220008AP2003/04/25Labeling Revision
020220007AP1999/12/27Manufacturing Change or Addition
020220006AP1998/11/25Control Supplement
020220005AP1998/11/03Control Supplement
020220004AP1997/06/05Control Supplement
020220002AP1997/07/23Patient Population Altered
020220001AP1995/05/30Labeling Revision
020220000AP1995/05/10Approval