HUMULIN R KWIKPEN(INSULIN HUMAN) - 美国FDA药品数据库

药品名称	HUMULIN R KWIKPEN
申请号	018780	产品号	002
活性成分	INSULIN HUMAN	市场状态	处方药
剂型或给药途径	SOLUTION;SUBCUTANEOUS	规格	1500 UNITS/3ML (500 UNITS/ML)
治疗等效代码		参比药物	是
批准日期	2015/12/29	申请机构	ELI LILLY AND CO
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
018780	153	AP	Letter	2016/07/12	下载
018780	152	AP	Label	2015/12/31	下载
018780	152	AP	Letter	2015/12/30	下载
018780	150	AP	Label	2015/03/03	下载
018780	150	AP	Letter	2015/04/01	下载
018780	148	AP	Label	2014/09/26	下载
018780	135	AP	Letter	2015/12/30	下载
018780	135	AP	Label	2015/12/31	下载
018780	133	AP	Letter	2011/11/02	下载
018780	132	AP	Letter	2013/03/12	下载
018780	132	AP	Label	2013/03/12	下载
018780	128	AP	Letter	2010/06/15	下载
018780	128	AP	Label	2010/06/24	下载
018780	124	AP	Letter	2011/03/24	下载
018780	124	AP	Label	2011/03/28	下载
018780	120	AP	Letter	2011/03/29	下载
018780	120	AP	Label	2011/04/01	下载
018780	114	AP	Label	2007/09/11	下载
018780	114	AP	Letter	2007/09/11	下载
018780	095	AP	Label	2007/08/23	下载
018780	095	AP	Letter	2007/08/27	下载
018780	094	AP	Letter	2007/09/11	下载
018780	086	AP	Letter	2005/03/03	下载
018780	086	AP	Label	2005/03/03	下载
018780	080	AP	Letter	2003/11/25	下载
018780	080	AP	Label	2003/12/01	下载
018780	078	AP	Label	2003/03/05	下载
018780	078	AP	Letter	2004/06/07	下载
018780	067	AP	Label	2003/03/05	下载
018780	067	AP	Letter	2004/06/07	下载
018780	066	AP	Letter	2003/05/29	下载
018780	037	AP	Review	2003/06/17	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
018780	155	AP	2016/06/24	Manufacturing Change or Addition
018780	154	AP	2016/02/26	Manufacturing Change or Addition
018780	153	AP	2016/07/08	Labeling Revision
018780	152	AP	2015/12/29	Labeling Revision
018780	151	AP	2015/10/08	Manufacturing Change or Addition
018780	150	AP	2015/02/25	Labeling Revision
018780	149	AP	2014/10/30	Manufacturing Change or Addition
018780	148	AP	2014/09/23	Manufacturing Change or Addition
018780	147	AP	2014/06/20	Manufacturing Change or Addition
018780	146	AP	2014/03/18	Manufacturing Change or Addition
018780	145	AP	2013/08/15	Manufacturing Change or Addition
018780	144	AP	2013/05/31	Manufacturing Change or Addition
018780	143	AP	2013/05/30	Manufacturing Change or Addition
018780	142	AP	2013/05/10	Manufacturing Change or Addition
018780	141	AP	2012/11/07	Manufacturing Change or Addition
018780	139	AP	2013/01/09	Manufacturing Change or Addition
018780	135	AP	2015/12/29	Labeling Revision
018780	133	AP	2011/10/30	Labeling Revision
018780	132	AP	2013/03/09	Labeling Revision
018780	128	AP	2010/06/10	Labeling Revision
018780	127	AP	2012/03/29	Manufacturing Change or Addition
018780	124	AP	2011/03/21	Labeling Revision
018780	120	AP	2011/03/25	New Route of Administration
018780	114	AP	2007/09/10	Labeling Revision
018780	095	AP	2007/08/22	Labeling Revision
018780	094	AP	2007/09/07	Labeling Revision
018780	086	AP	2005/02/25	Control Supplement
018780	080	AP	2003/11/10	Manufacturing Change or Addition
018780	078	AP	2003/02/10	Manufacturing Change or Addition
018780	076	AP	2002/10/25	Control Supplement
018780	075	AP	2002/08/29	Control Supplement
018780	074	AP	2002/08/29	Control Supplement
018780	073	AP	2002/08/29	Control Supplement
018780	072	AP	2002/08/21	Control Supplement
018780	071	AP	2002/08/21	Control Supplement
018780	070	AP	2002/10/10	Control Supplement
018780	069	AP	2002/03/13	Control Supplement
018780	067	AP	2003/02/10	Labeling Revision
018780	066	AP	2003/04/14	Labeling Revision
018780	065	AP	2002/08/29	Control Supplement
018780	064	AP	2000/04/19	Control Supplement
018780	063	AP	1999/11/02	Control Supplement
018780	061	AP	1999/02/25	Control Supplement
018780	058	AP	1998/08/06	Package Change
018780	057	AP	1998/02/20	Control Supplement
018780	056	AP	1997/04/16	Control Supplement
018780	056	AP	2016/09/22	Manufacturing Change or Addition
018780	055	AP	1997/04/16	Labeling Revision
018780	054	AP	1997/01/28	Manufacturing Change or Addition
018780	052	AP	1996/07/26	Control Supplement
018780	051	AP	1996/07/10	Labeling Revision
018780	050	AP	1996/07/26	Control Supplement
018780	049	AP	1996/04/25	Manufacturing Change or Addition
018780	048	AP	1996/02/15	Control Supplement
018780	047	AP	1996/02/14	Control Supplement
018780	046	AP	1995/11/09	Labeling Revision
018780	045	AP	1995/09/29	Labeling Revision
018780	044	AP	1995/03/09	Control Supplement
018780	043	AP	1995/02/22	Labeling Revision
018780	042	AP	1994/03/31	New Dosage Regimen
018780	041	AP	1992/12/07	Package Change
018780	040	AP	1993/05/10	Manufacturing Change or Addition
018780	039	AP	1994/06/14	Control Supplement
018780	038	AP	1992/01/27	Labeling Revision
018780	037	AP	1994/01/11	Package Change
018780	036	AP	1991/03/12	Labeling Revision
018780	035	AP	1991/11/15	Control Supplement
018780	034	AP	1990/09/24	Control Supplement
018780	033	AP	1990/08/17	Control Supplement
018780	032	AP	1989/01/23	Labeling Revision
018780	031	AP	1988/07/29	Control Supplement
018780	030	AP	1989/02/01	Control Supplement
018780	029	AP	1988/03/24	Labeling Revision
018780	028	AP	1987/10/27	Manufacturing Change or Addition
018780	027	AP	1988/06/10	Control Supplement
018780	026	AP	1987/07/10	Labeling Revision
018780	024	AP	1986/05/28	Control Supplement
018780	023	AP	1987/07/13	Labeling Revision
018780	022	AP	1987/05/07	Control Supplement
018780	021	AP	1987/07/28	Labeling Revision
018780	020	AP	1986/09/15	Control Supplement
018780	018	AP	1986/04/10	Control Supplement
018780	016	AP	1985/03/08	Control Supplement
018780	014	AP	1984/11/23	Control Supplement
018780	013	AP	1984/12/26	Control Supplement
018780	012	AP	1984/02/28	Labeling Revision
018780	011	AP	1984/01/26	Control Supplement
018780	009	AP	1984/07/25	Control Supplement
018780	008	AP	1983/10/12	Labeling Revision
018780	007	AP	1983/08/24	Labeling Revision
018780	005	AP	1983/03/14	Control Supplement
018780	004	AP	1983/01/27	Labeling Revision
018780	003	AP	1983/01/31	Control Supplement
018780	002	AP	1982/12/02	Formulation Revision
018780	001	AP	1982/12/02	Labeling Revision
018780	000	AP	1982/10/28	Approval

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