药品名称MPI DMSA KIDNEY REAGENT
申请号017944产品号001
活性成分TECHNETIUM TC-99M SUCCIMER KIT市场状态停止上市
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1982/05/18申请机构GE HEALTHCARE
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
017944018APLetter2003/11/25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
017944024AP2014/02/28Manufacturing Change or Addition
017944023AP2013/11/22Manufacturing Change or Addition
017944018AP2003/11/24Labeling Revision
017944016AP2002/11/25Control Supplement
017944015AP2001/04/10Manufacturing Change or Addition
017944014AP2000/09/29Manufacturing Change or Addition
017944013AP1999/11/12Control Supplement
017944012AP1995/11/16Control Supplement
017944011AP1993/07/15Manufacturing Change or Addition
017944010AP1994/03/17Control Supplement
017944009AP1989/11/15Manufacturing Change or Addition
017944007AP1989/02/17Control Supplement
017944006AP1989/02/17Manufacturing Change or Addition
017944005AP1985/03/12Labeling Revision
017944004AP1985/01/30Control Supplement
017944003AP1986/01/23Expiration Date Change
017944002AP1983/05/27Labeling Revision
017944001AP1986/04/10Manufacturing Change or Addition
017944000AP1982/05/18Approval