药品名称ORUDIS
申请号018754产品号001
活性成分KETOPROFEN市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格25MG
治疗等效代码参比药物
批准日期1987/07/31申请机构WYETH AYERST LABORATORIES
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
018754027APLetter2006/01/20下载
018754026APLetter2003/08/26下载
018754025APReview2003/09/11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
018754027AP2006/01/18Labeling Revision
018754026AP2003/08/18Labeling Revision
018754025AP1997/08/05Labeling Revision
018754024AP1995/02/08Labeling Revision
018754023AP1994/07/11Control Supplement
018754022AP1994/07/11Control Supplement
018754020AP1995/02/17Manufacturing Change or Addition
018754018AP1994/01/06New or Modified Indication
018754015AP1988/10/26Package Change
018754014AP1989/10/05Package Change
018754013AP1990/01/16Formulation Revision
018754012AP1989/01/11Manufacturing Change or Addition
018754011AP1988/02/18Labeling Revision
018754010AP1990/09/05Package Change
018754009AP1989/10/05Package Change
018754007AP1987/07/23Labeling Revision
018754006AP1989/04/10Manufacturing Change or Addition
018754005AP1986/07/16Manufacturing Change or Addition
018754004AP1987/07/31Labeling Revision
018754003AP1987/07/31New or Modified Indication
018754002AP1987/03/17Manufacturing Change or Addition
018754001AP1986/01/27Labeling Revision
018754000AP1986/01/09Approval