药品名称ORAP
申请号017473产品号003
活性成分PIMOZIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格1MG
治疗等效代码AB参比药物
批准日期1997/08/27申请机构TEVA PHARMACEUTICALS USA 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
017473046APLabel2011/09/30下载
017473046APLetter2011/10/03下载
017473046APReview2012/01/27下载
017473045APLabel2010/12/04下载
017473045APLetter2010/12/06下载
017473043APLabel2009/07/21下载
017473043APLetter2009/07/23下载
017473041APLetter2009/05/06下载
017473041APLabel2009/05/11下载
017473039APLetter2003/11/05下载
017473038APLetter2002/11/14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
017473049AP2015/05/11Manufacturing Change or Addition
017473048AP2015/01/26Manufacturing Change or Addition
017473047AP2013/08/01Manufacturing Change or Addition
017473046AP2011/09/27Labeling Revision
017473045AP2010/12/01Labeling Revision
017473043AP2009/07/19Labeling Revision
017473041AP2009/04/28Labeling Revision
017473039AP2003/10/27Labeling Revision
017473038AP2002/11/14Labeling Revision
017473036AP1999/11/09Labeling Revision
017473035AP1999/11/12Manufacturing Change or Addition
017473034AP2000/05/23Control Supplement
017473033AP1999/11/09Labeling Revision
017473032AP1998/05/20Labeling Revision
017473031AP1998/03/23Control Supplement
017473030AP1997/10/23Manufacturing Change or Addition
017473029AP1997/08/27Manufacturing Change or Addition
017473027AP1997/05/30Control Supplement
017473026AP1997/01/07Control Supplement
017473024AP1996/07/09Control Supplement
017473023AP1995/11/22Manufacturing Change or Addition
017473022AP1995/11/22Manufacturing Change or Addition
017473021AP1995/10/20Control Supplement
017473020AP1994/11/02Control Supplement
017473019AP1995/05/10Manufacturing Change or Addition
017473018AP1994/12/12Control Supplement
017473017AP1990/12/21Manufacturing Change or Addition
017473016AP1994/07/27Labeling Revision
017473015AP1994/07/27Patient Population Altered
017473014AP1990/02/12Manufacturing Change or Addition
017473013AP1988/12/16Control Supplement
017473012AP1990/12/21Labeling Revision
017473011AP1988/10/27Labeling Revision
017473010AP1988/11/29Control Supplement
017473009AP1987/10/07Labeling Revision
017473008AP1986/09/17Labeling Revision
017473007AP1987/04/20Expiration Date Change
017473006AP1985/08/15Control Supplement
017473004AP1985/03/21Labeling Revision
017473002AP1985/03/11Labeling Revision
017473001AP1984/11/14Manufacturing Change or Addition
017473000AP1984/07/31Approval