ISOVUE-300(IOPAMIDOL) - 美国FDA药品数据库

药品名称	ISOVUE-300
申请号	018735	产品号	002
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	AP	参比药物	是
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
无
历史专利信息
无

与本品相关的市场独占权保护信息
独占权代码	失效日期
无
历史市场独占权保护信息
无

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
018735	056	AP	Letter	2015/07/09	下载
018735	056	AP	Label	2015/07/09	下载
018735	054	AP	Label	2012/08/02	下载
018735	054	AP	Letter	2012/08/03	下载
018735	044	AP	Letter	2002/06/20	下载
018735	043	AP	Letter	2002/07/08	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
018735	056	AP	2015/07/06	Labeling Revision
018735	055	AP	2015/05/14	Manufacturing Change or Addition
018735	054	AP	2012/08/01	Labeling Revision
018735	051	AP	2006/03/10	Package Change
018735	050	AP	2005/07/26	Manufacturing Change or Addition
018735	049	AP	2005/12/01	Control Supplement
018735	048	AP	2003/10/07	Control Supplement
018735	047	AP	2000/06/01	Manufacturing Change or Addition
018735	046	AP	1999/12/09	Manufacturing Change or Addition
018735	045	AP	1999/11/16	Manufacturing Change or Addition
018735	044	AP	2002/06/20	Labeling Revision
018735	043	AP	2002/07/08	Labeling Revision
018735	041	AP	1997/05/14	Manufacturing Change or Addition
018735	040	AP	1997/03/19	Control Supplement
018735	039	AP	1996/06/24	Manufacturing Change or Addition
018735	038	AP	1995/09/29	Labeling Revision
018735	037	AP	1995/05/15	Labeling Revision
018735	036	AP	1995/05/15	Patient Population Altered
018735	035	AP	1994/03/21	Control Supplement
018735	034	AP	1993/09/09	Package Change
018735	033	AP	1996/03/04	New Dosage Regimen
018735	032	AP	1992/12/21	Control Supplement
018735	029	AP	1992/09/30	Labeling Revision
018735	028	AP	1992/09/30	Package Change
018735	025	AP	1992/07/06	New Dosage Regimen
018735	024	AP	1991/07/29	Labeling Revision
018735	023	AP	1990/09/21	Patient Population Altered
018735	022	AP	1991/01/03	Package Change
018735	021	AP	1990/05/30	Patient Population Altered
018735	019	AP	1990/11/27	Package Change
018735	018	AP	1990/11/19	Package Change
018735	017	AP	1989/05/15	Labeling Revision
018735	016	AP	1989/04/24	Control Supplement
018735	015	AP	1989/09/18	Manufacturing Change or Addition
018735	014	AP	1988/12/07	Package Change
018735	013	AP	1989/02/06	Control Supplement
018735	012	AP	1989/10/04	Patient Population Altered
018735	011	AP	1989/02/06	Package Change
018735	010	AP	1990/01/18	Patient Population Altered
018735	009	AP	1987/07/02	Manufacturing Change or Addition
018735	008	AP	1987/07/07	New or Modified Indication
018735	007	AP	1987/02/24	Manufacturing Change or Addition
018735	006	AP	1986/09/24	Formulation Revision
018735	005	AP	1986/06/26	Labeling Revision
018735	004	AP	1987/01/28	Manufacturing Change or Addition
018735	003	AP	1986/10/21	New or Modified Indication
018735	002	AP	1986/09/10	New or Modified Indication
018735	001	AP	1986/03/05	Expiration Date Change
018735	000	AP	1985/12/31	Approval

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