RENOGRAFIN-60(DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM)

药品名称	RENOGRAFIN-60
申请号	010040	产品号	006
活性成分	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	市场状态	停止上市
剂型或给药途径	INJECTABLE;INJECTION	规格	52%;8%
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	BRACCO DIAGNOSTICS INC
化学类型		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
010040	171	AP	Letter	2015/07/10	下载
010040	171	AP	Label	2015/07/13	下载
010040	168	AP	Letter	2002/10/23	下载
010040	163	AP	Letter	2003/10/01	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
010040	171	AP	2015/07/06	Labeling Revision
010040	168	AP	2002/10/23	Labeling Revision
010040	167	AP	2000/06/29	Manufacturing Change or Addition
010040	166	AP	1994/09/09	Labeling Revision
010040	163	AP	2003/09/25	Practioner Draft Labeling
010040	162	AP	1989/07/07	Labeling Revision
010040	160	AP	1987/06/08	Control Supplement
010040	159	AP	1985/11/25	Labeling Revision
010040	158	AP	1985/07/23	Labeling Revision
010040	157	AP	1985/07/23	Labeling Revision
010040	156	AP	1985/06/06	Labeling Revision
010040	155	AP	1985/06/05	Labeling Revision
010040	154	AP	1985/06/06	Labeling Revision
010040	153	AP	1985/07/23	Labeling Revision
010040	152	AP	1985/07/23	Labeling Revision
010040	151	AP	1985/06/06	Labeling Revision
010040	150	AP	1985/07/23	Labeling Revision
010040	149	AP	1985/06/12	Labeling Revision
010040	148	AP	1985/06/12	Labeling Revision
010040	147	AP	1985/06/06	Labeling Revision
010040	146	AP	1985/06/12	Labeling Revision
010040	145	AP	1985/01/28	Manufacturing Change or Addition
010040	144	AP	1985/05/23	Manufacturing Change or Addition
010040	143	AP	1984/04/03	General Efficacy (MarkIV)
010040	142	AP	1985/05/23	Manufacturing Change or Addition
010040	140	AP	1983/02/02	Labeling Revision
010040	139	AP	1984/01/06	Package Change
010040	138	AP	1985/01/14	Control Supplement
010040	137	AP	1982/11/09	Control Supplement
010040	135	AP	1982/02/24	Control Supplement
010040	134	AP	1991/03/05	Formulation Revision
010040	122	AP	1982/03/31	Labeling Revision
010040	121	AP	1982/09/27	General Efficacy (MarkIV)
010040	120	AP	1981/07/01	Control Supplement
010040	118	AP	1980/08/01	Final Printed Labeling - MarkIV
010040	117	AP	1980/06/04	Labeling Revision
010040	116	AP	1980/07/01	Labeling Revision
010040	115	AP	1980/06/20	Labeling Revision
010040	114	AP	1980/04/14	Labeling Revision
010040	113	AP	1980/06/04	Labeling Revision
010040	111	AP	1982/06/30	Labeling Revision
010040	110	AP	1980/03/14	Labeling Revision
010040	109	AP	1983/01/26	Labeling Revision
010040	108	AP	1979/08/03	Control Supplement
010040	107	AP	1983/07/10	General Efficacy (MarkIV)
010040	105	AP	1982/06/30	Labeling Revision
010040	103	AP	1980/06/30	Labeling Revision
010040	102	AP	1979/06/08	Labeling Revision
010040	101	AP	1979/06/08	Labeling Revision
010040	100	AP	1979/06/08	Labeling Revision
010040	099	AP	1980/01/24	Control Supplement
010040	098	AP	1979/10/12	Labeling Revision
010040	097	AP	1979/10/12	Labeling Revision
010040	096	AP	1979/09/13	Labeling Revision
010040	095	AP	1980/03/19	Labeling Revision
010040	094	AP	1979/09/13	Labeling Revision
010040	093	AP	1979/06/26	Labeling Revision
010040	092	AP	1979/02/16	Control Supplement
010040	091	AP	1978/12/28	Formulation Revision
010040	089	AP	1978/02/23	Control Supplement
010040	088	AP	1978/09/15	Control Supplement
010040	087	AP	1978/03/14	Labeling Revision
010040	086	AP	1977/11/01	Labeling Revision
010040	085	AP	1977/10/21	Labeling Revision
010040	083	AP	1979/03/30	Control Supplement
010040	082	AP	1977/01/11	Labeling (MarkIV)
010040	081	AP	1977/01/11	Control Supplement
010040	080	AP	1977/01/11	Package Change
010040	079	AP	1976/12/06	Labeling Revision
010040	078	AP	1977/08/22	Labeling Revision
010040	077	AP	1976/12/14	Package Change
010040	076	AP	1976/12/02	Labeling Revision
010040	075	AP	1978/01/31	Labeling Revision
010040	074	AP	1976/09/13	Labeling Revision
010040	073	AP	1976/09/10	Labeling Revision
010040	072	AP	1976/09/10	Labeling Revision
010040	071	AP	1976/09/06	Labeling Revision
010040	070	AP	1976/09/13	Labeling Revision
010040	069	AP	1976/09/13	Labeling Revision
010040	068	AP	1976/09/09	Labeling Revision
010040	067	AP	1976/09/10	Labeling Revision
010040	066	AP	1976/05/26	Control Supplement
010040	065	AP	1976/06/16	Labeling Revision
010040	064	AP	1976/05/06	Expiration Date Change
010040	063	AP	1976/05/06	Labeling Revision
010040	062	AP	1976/05/05	Labeling Revision
010040	061	AP	1976/05/05	Labeling Revision
010040	059	AP	1976/05/05	Expiration Date Change
010040	058	AP	1976/05/06	Labeling Revision
010040	057	AP	1976/05/06	Labeling Revision
010040	056	AP	1975/09/24	Control Supplement
010040	055	AP	1975/09/30	Labeling Revision
010040	054	AP	1975/09/30	Labeling Revision
010040	053	AP	1975/05/27	Other Amendment
010040	033	AP	1977/06/17	Control Supplement
010040	000	AP	1955/08/02	Approval

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