OMNIPAQUE 300(IOHEXOL) - 美国FDA药品数据库

药品名称	OMNIPAQUE 300
申请号	018956	产品号	003
活性成分	IOHEXOL	市场状态	处方药
剂型或给药途径	SOLUTION;INJECTION, ORAL, RECTAL	规格	64.7%
治疗等效代码		参比药物	是
批准日期	1985/12/26	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
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
018956	095	AP	Label	2015/07/09	下载
018956	095	AP	Letter	2015/07/10	下载
018956	076	AP	Letter	2007/10/04	下载
018956	065	AP	Letter	2005/03/30	下载
018956	062	AP	Letter	2004/12/29	下载
018956	058	AP	Letter	2004/03/10	下载
018956	049	AP	Letter	2002/12/23	下载
018956	043	AP	Review	1998/05/11	下载
018956	039	AP	Letter	2002/12/23	下载
018956	028	AP	Review	2003/08/05	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
018956	096	AP	2015/10/21	Manufacturing Change or Addition
018956	095	AP	2015/07/06	Labeling Revision
018956	094	AP	2015/03/03	Manufacturing Change or Addition
018956	093	AP	2014/06/19	Manufacturing Change or Addition
018956	092	AP	2013/11/20	Manufacturing Change or Addition
018956	091	AP	2014/02/10	Manufacturing Change or Addition
018956	089	AP	2013/08/21	Manufacturing Change or Addition
018956	076	AP	2007/10/01	Labeling Revision
018956	065	AP	2005/03/25	Manufacturing Change or Addition
018956	062	AP	2004/12/27	Labeling Revision
018956	058	AP	2004/03/05	Labeling Revision
018956	054	AP	2002/11/20	Manufacturing Change or Addition
018956	053	AP	2002/08/05	Manufacturing Change or Addition
018956	052	AP	2000/12/19	Control Supplement
018956	051	AP	1998/09/08	Control Supplement
018956	049	AP	2002/12/23	Labeling Revision
018956	046	AP	1995/08/18	Manufacturing Change or Addition
018956	045	AP	1994/11/04	Manufacturing Change or Addition
018956	044	AP	1995/08/18	Control Supplement
018956	043	AP	1995/06/15	Labeling Revision
018956	042	AP	1995/11/28	Control Supplement
018956	041	AP	1994/09/30	Package Change
018956	040	AP	1992/10/20	Control Supplement
018956	039	AP	2002/12/23	Labeling Revision
018956	038	AP	1992/09/30	Manufacturing Change or Addition
018956	037	AP	1992/12/11	Package Change
018956	036	AP	1994/06/01	Labeling Revision
018956	035	AP	1994/06/01	Package Change
018956	034	AP	1993/03/01	Package Change
018956	033	AP	1993/03/01	Labeling Revision
018956	032	AP	1993/03/01	Control Supplement
018956	031	AP	1993/03/01	Manufacturing Change or Addition
018956	030	AP	1995/12/04	Control Supplement
018956	029	AP	1990/08/24	Package Change
018956	028	AP	1993/07/13	New Route of Administration
018956	027	AP	1992/03/26	Control Supplement
018956	026	AP	1989/11/30	Patient Population Altered
018956	024	AP	1989/05/03	Labeling Revision
018956	023	AP	1989/07/28	New or Modified Indication
018956	022	AP	1989/07/28	Patient Population Altered
018956	021	AP	1989/06/30	New or Modified Indication
018956	020	AP	1989/06/30	New or Modified Indication
018956	019	AP	1989/01/04	Control Supplement
018956	018	AP	1989/03/31	New or Modified Indication
018956	017	AP	1988/11/30	New or Modified Indication
018956	016	AP	1988/04/18	Manufacturing Change or Addition
018956	015	AP	1988/05/24	New or Modified Indication
018956	014	AP	1988/07/29	New or Modified Indication
018956	013	AP	1988/01/27	Control Supplement
018956	012	AP	1988/02/01	Patient Population Altered
018956	010	AP	1989/05/22	Manufacturing Change or Addition
018956	009	AP	1987/05/12	New or Modified Indication
018956	008	AP	1993/12/23	Manufacturing Change or Addition
018956	007	AP	1987/06/04	Package Change
018956	006	AP	1987/05/27	Labeling Revision
018956	004	AP	1987/04/21	Labeling Revision
018956	003	AP	1986/11/20	Labeling Revision
018956	002	AP	1987/02/05	Manufacturing Change or Addition
018956	001	AP	1986/11/26	New or Modified Indication
018956	000	AP	1985/12/26	Approval

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