药品名称ISOVUE-M 300
申请号018735产品号004
活性成分IOPAMIDOL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格61%
治疗等效代码参比药物
批准日期1985/12/31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
018735056APLetter2015/07/09下载
018735056APLabel2015/07/09下载
018735054APLabel2012/08/02下载
018735054APLetter2012/08/03下载
018735044APLetter2002/06/20下载
018735043APLetter2002/07/08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
018735056AP2015/07/06Labeling Revision
018735055AP2015/05/14Manufacturing Change or Addition
018735054AP2012/08/01Labeling Revision
018735051AP2006/03/10Package Change
018735050AP2005/07/26Manufacturing Change or Addition
018735049AP2005/12/01Control Supplement
018735048AP2003/10/07Control Supplement
018735047AP2000/06/01Manufacturing Change or Addition
018735046AP1999/12/09Manufacturing Change or Addition
018735045AP1999/11/16Manufacturing Change or Addition
018735044AP2002/06/20Labeling Revision
018735043AP2002/07/08Labeling Revision
018735041AP1997/05/14Manufacturing Change or Addition
018735040AP1997/03/19Control Supplement
018735039AP1996/06/24Manufacturing Change or Addition
018735038AP1995/09/29Labeling Revision
018735037AP1995/05/15Labeling Revision
018735036AP1995/05/15Patient Population Altered
018735035AP1994/03/21Control Supplement
018735034AP1993/09/09Package Change
018735033AP1996/03/04New Dosage Regimen
018735032AP1992/12/21Control Supplement
018735029AP1992/09/30Labeling Revision
018735028AP1992/09/30Package Change
018735025AP1992/07/06New Dosage Regimen
018735024AP1991/07/29Labeling Revision
018735023AP1990/09/21Patient Population Altered
018735022AP1991/01/03Package Change
018735021AP1990/05/30Patient Population Altered
018735019AP1990/11/27Package Change
018735018AP1990/11/19Package Change
018735017AP1989/05/15Labeling Revision
018735016AP1989/04/24Control Supplement
018735015AP1989/09/18Manufacturing Change or Addition
018735014AP1988/12/07Package Change
018735013AP1989/02/06Control Supplement
018735012AP1989/10/04Patient Population Altered
018735011AP1989/02/06Package Change
018735010AP1990/01/18Patient Population Altered
018735009AP1987/07/02Manufacturing Change or Addition
018735008AP1987/07/07New or Modified Indication
018735007AP1987/02/24Manufacturing Change or Addition
018735006AP1986/09/24Formulation Revision
018735005AP1986/06/26Labeling Revision
018735004AP1987/01/28Manufacturing Change or Addition
018735003AP1986/10/21New or Modified Indication
018735002AP1986/09/10New or Modified Indication
018735001AP1986/03/05Expiration Date Change
018735000AP1985/12/31Approval