药品名称CIS-MDP
申请号018124产品号001
活性成分TECHNETIUM TC-99M MEDRONATE 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AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMALUCENCE INC
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
018124013APLetter2005/04/28下载
018124013APLabel2005/04/28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
018124027AP2016/05/17Manufacturing Change or Addition
018124024AP2015/05/26Manufacturing Change or Addition
018124023AP2014/02/21Manufacturing Change or Addition
018124021AP2013/07/18Manufacturing Change or Addition
018124013AP2005/04/19Control Supplement
018124012AP1997/05/27Control Supplement
018124011AP1989/09/28Labeling Revision
018124010AP1986/04/02Manufacturing Change or Addition
018124009AP1986/01/27Manufacturing Change or Addition
018124008AP1985/08/02Manufacturing Change or Addition
018124007AP1985/04/29Manufacturing Change or Addition
018124003AP1984/03/27Practioner Draft Labeling
018124002AP1984/03/27Labeling Revision
018124001AP1988/08/18Manufacturing Change or Addition
018124000AP1979/08/29Approval