药品名称TECHNESCAN
申请号018321产品号001
活性成分TECHNETIUM TC-99M OXIDRONATE KIT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格N/A
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MALLINCKRODT NUCLEAR MEDICINE LLC
化学类型New formulation or new manufacturer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
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
018321021AP2014/06/17Manufacturing Change or Addition
018321020AP2013/03/14Manufacturing Change or Addition
018321016AP1998/04/08Manufacturing Change or Addition
018321015AP1994/07/14Labeling Revision
018321014AP1988/09/30Manufacturing Change or Addition
018321013AP1987/11/05Manufacturing Change or Addition
018321010AP1986/01/10Manufacturing Change or Addition
018321008AP1989/04/28Patient Population Altered
018321006AP1983/02/03Control Supplement
018321005AP1996/02/29Control Supplement
018321000AP1981/02/18Approval