药品名称DOLOBID
申请号018445产品号002
活性成分DIFLUNISAL市场状态停止上市
剂型或给药途径TABLET;ORAL规格500MG
治疗等效代码参比药物
批准日期1982/04/19申请机构MERCK AND CO 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
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
018445058APLetter2007/03/23下载
018445058APLabel2007/03/23下载
018445057APLabel2006/01/25下载
018445057APLetter2006/01/30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
018445058AP2007/03/16Labeling Revision
018445057AP2006/01/24Labeling Revision
018445054AP1997/12/01Control Supplement
018445053AP1998/05/15Labeling Revision
018445052AP1998/05/15Labeling Revision
018445051AP1996/03/01Manufacturing Change or Addition
018445050AP1997/04/17Labeling Revision
018445049AP1994/08/18Control Supplement
018445048AP1994/08/22Labeling Revision
018445047AP1994/08/22Labeling Revision
018445046AP1994/08/22Labeling Revision
018445044AP1991/12/06Labeling Revision
018445043AP1991/12/06Control Supplement
018445042AP1991/11/19Control Supplement
018445040AP1989/01/09Labeling Revision
018445038AP1989/01/09Package Change
018445037AP1989/04/21Manufacturing Change or Addition
018445036AP1989/01/09Labeling Revision
018445035AP1988/05/03Manufacturing Change or Addition
018445034AP1988/02/02Labeling Revision
018445033AP1988/02/02Labeling Revision
018445032AP1988/02/02Labeling Revision
018445031AP1988/02/02Labeling Revision
018445030AP1988/02/02Labeling Revision
018445028AP1994/03/28Control Supplement
018445027AP1988/02/02Labeling Revision
018445026AP1986/08/15Labeling Revision
018445025AP1986/08/15Labeling Revision
018445024AP1988/02/02Labeling Revision
018445022AP1989/04/21Manufacturing Change or Addition
018445021AP1986/02/03Control Supplement
018445019AP1985/09/30Manufacturing Change or Addition
018445018AP1985/02/21Manufacturing Change or Addition
018445017AP1985/02/21Manufacturing Change or Addition
018445016AP1984/11/20Manufacturing Change or Addition
018445015AP1984/10/03Manufacturing Change or Addition
018445012AP1984/12/11Control Supplement
018445010AP1984/05/03Manufacturing Change or Addition
018445009AP1984/06/25Manufacturing Change or Addition
018445008AP1985/01/09Labeling Revision
018445007AP1983/10/27Labeling Revision
018445003AP1983/10/27Labeling Revision
018445001AP1986/02/03Control Supplement
018445000AP1982/04/19Approval