药品名称SERAX
申请号015539产品号008
活性成分OXAZEPAM市场状态停止上市
剂型或给药途径TABLET;ORAL规格15MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALPHARMA US PHARMACEUTICALS DIVISION
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
015539052APLetter2001/08/08下载
015539052APLabel2001/08/08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
015539054AP2001/11/30Manufacturing Change or Addition
015539053AP2000/04/05Labeling Revision
015539052AP2001/08/08Labeling Revision
015539048AP1992/01/21Package Change
015539046AP1988/11/08Manufacturing Change or Addition
015539045AP1989/02/01Control Supplement
015539044AP1989/11/17Manufacturing Change or Addition
015539043AP1988/07/21Control Supplement
015539040AP1989/06/14Manufacturing Change or Addition
015539037AP1987/04/07Manufacturing Change or Addition
015539036AP1987/02/02Package Change
015539035AP1986/09/08Manufacturing Change or Addition
015539034AP1986/07/16Manufacturing Change or Addition
015539027AP1984/02/02Labeling Revision
015539021AP1986/06/11Formulation Revision
015539018AP1985/11/22Formulation Revision
015539017AP1980/05/29Labeling Revision
015539015AP1979/12/03Package Change
015539013AP1978/01/24Labeling Revision
015539009AP1975/05/07Control Supplement
015539008AP1976/06/15Control Supplement
015539000AP1965/06/04Approval