药品名称CARDIOGEN-82
申请号019414产品号001
活性成分RUBIDIUM CHLORIDE RB-82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1989/12/29申请机构BRACCO DIAGNOSTICS INC
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
019414014APLabel2012/02/09下载
019414014APLetter2012/02/10下载
019414012APLetter2010/07/30下载
019414012APLabel2010/07/31下载
019414011APLetter2009/07/23下载
019414011APLabel2009/07/23下载
019414006APLetter2001/04/11下载
019414000APOther Important Information from FDA2012/01/12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
019414016AP2014/12/05Manufacturing Change or Addition
019414015AP2013/04/22Manufacturing Change or Addition
019414014AP2012/02/08Labeling Revision
019414012AP2010/07/28Efficacy Supplement with Clinical Data to Support
019414011AP2009/07/21Labeling Revision
019414006AP2001/04/05Manufacturing Change or Addition
019414005AP1999/03/23Manufacturing Change or Addition
019414004AP1998/05/29Manufacturing Change or Addition
019414003AP1997/11/21Manufacturing Change or Addition
019414002AP1991/11/14Manufacturing Change or Addition
019414001AP1990/03/06Manufacturing Change or Addition
019414000AP1989/12/29Approval