药品名称LOTRISONE
申请号018827产品号001
活性成分BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE市场状态处方药
剂型或给药途径CREAM;TOPICAL规格EQ 0.05% BASE;1%
治疗等效代码AB参比药物
批准日期1984/07/10申请机构MERCK SHARP AND DOHME CORP
化学类型New combination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
018827046APLetter2014/04/22下载
018827046APLabel2014/04/22下载
018827042APLetter2009/05/13下载
018827042APLabel2009/07/08下载
018827038APLetter2008/01/29下载
018827038APLabel2008/01/30下载
018827025APLabel2003/03/28下载
018827025APLetter2003/04/15下载
018827022APLetter2003/07/31下载
018827022APLabel2005/07/29下载
018827007APLabel2003/04/15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
018827046AP2014/04/21Labeling Revision
018827042AP2009/05/11Labeling Revision
018827038AP2008/01/25Labeling Revision
018827025AP2003/03/27Labeling Revision
018827024AP2002/01/10Control Supplement
018827022AP2001/10/03Patient Population Altered
018827021AP2001/02/28Control Supplement
018827020AP2001/10/03Labeling Revision
018827019AP2000/02/02Control Supplement
018827018AP1999/05/14Control Supplement
018827017AP1998/11/10Package Change
018827016AP1998/05/18Control Supplement
018827015AP1998/07/31Control Supplement
018827014AP1998/06/15Control Supplement
018827012AP1995/01/30Control Supplement
018827011AP1995/01/30Manufacturing Change or Addition
018827010AP1994/10/06Package Change
018827009AP2001/10/03Labeling Revision
018827008AP1990/09/11Control Supplement
018827007AP2001/10/03Labeling Revision
018827006AP1990/08/01Control Supplement
018827005AP1987/10/29Manufacturing Change or Addition
018827004AP1986/09/12Manufacturing Change or Addition
018827003AP1986/05/20Control Supplement
018827002AP1986/04/23Manufacturing Change or Addition
018827001AP1985/02/22Package Change
018827000AP1984/07/10Approval