药品名称8-MOP
申请号009048产品号001
活性成分METHOXSALEN市场状态处方药
剂型或给药途径CAPSULE;ORAL规格10MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT PHARMACEUTICALS INTERNATIONAL
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
009048037APLabel2003/03/28下载
009048037APLetter2003/04/15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
009048048AP2015/07/30Manufacturing Change or Addition
009048047AP2015/07/28Manufacturing Change or Addition
009048046AP2013/09/20Labeling Revision
009048045AP2013/03/22Manufacturing Change or Addition
009048040AP2001/10/31Control Supplement
009048038AP2000/04/05Control Supplement
009048037AP2003/03/26Labeling Revision
009048036AP1998/04/07Control Supplement
009048035AP1998/03/16Manufacturing Change or Addition
009048034AP1997/09/23Control Supplement
009048033AP1997/09/23Control Supplement
009048031AP1996/01/25Manufacturing Change or Addition
009048030AP1988/03/23New or Modified Indication
009048025AP1984/04/16Labeling Revision
009048022AP1983/04/21Labeling Revision
009048021AP1982/05/07Labeling Revision
009048020AP1982/05/07Labeling Revision
009048006AP1975/04/04Labeling Revision
009048005AP1974/11/13Supplement
009048000AP1954/12/03Approval