HUMALOG PEN(INSULIN LISPRO RECOMBINANT) - 美国FDA药品数据库

药品名称	HUMALOG PEN
申请号	020563	产品号	002
活性成分	INSULIN LISPRO RECOMBINANT	市场状态	停止上市
剂型或给药途径	INJECTABLE;INJECTION	规格	100 UNITS/ML
治疗等效代码		参比药物	否
批准日期	1998/08/06	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
5474978	2014/06/16			U-534	PDF格式
5514646	2013/05/07			U-534	PDF格式

与本品相关的市场独占权保护信息
独占权代码	失效日期
NR	2015/10/12
历史市场独占权保护信息
D-86	2007/06/02

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
020563	163	AP	Letter	2015/06/15	下载
020563	163	AP	Label	2015/06/15	下载
020563	157	AP	Letter	2015/02/27	下载
020563	157	AP	Label	2015/03/02	下载
020563	127	AP	Letter	2013/01/31	下载
020563	127	AP	Label	2013/02/01	下载
020563	124	AP	Letter	2015/03/16	下载
020563	124	AP	Label	2015/04/07	下载
020563	123	AP	Label	2012/10/15	下载
020563	123	AP	Letter	2012/10/16	下载
020563	117	AP	Label	2011/11/16	下载
020563	115	AP	Label	2013/03/11	下载
020563	115	AP	Letter	2013/03/13	下载
020563	105	AP	Letter	2011/05/24	下载
020563	105	AP	Label	2011/05/23	下载
020563	098	AP	Letter	2011/05/24	下载
020563	098	AP	Label	2011/05/23	下载
020563	091	AP	Label	2009/03/17	下载
020563	091	AP	Letter	2009/03/23	下载
020563	082	AP	Letter	2007/07/24	下载
020563	082	AP	Label	2007/07/24	下载
020563	076	AP	Label	2007/06/27	下载
020563	076	AP	Letter	2007/07/05	下载
020563	075	AP	Label	2007/09/11	下载
020563	075	AP	Letter	2007/09/11	下载
020563	065	AP	Label	2007/08/23	下载
020563	065	AP	Letter	2007/08/27	下载
020563	064	AP	Letter	2007/09/11	下载
020563	054	AP	Letter	2005/05/23	下载
020563	054	AP	Label	2005/05/23	下载
020563	046	AP	Letter	2004/04/29	下载
020563	046	AP	Label	2004/05/04	下载
020563	044	AP	Label	2004/06/07	下载
020563	044	AP	Letter	2003/11/25	下载
020563	041	AP	Label	2003/10/08	下载
020563	041	AP	Letter	2003/10/09	下载
020563	040	AP	Letter	2003/07/06	下载
020563	040	AP	Label	2003/07/08	下载
020563	036	AP	Letter	2004/01/22	下载
020563	036	AP	Label	2004/01/22	下载
020563	032	AP	Label	2003/04/03	下载
020563	032	AP	Letter	2003/04/16	下载
020563	027	AP	Label	2003/03/05	下载
020563	027	AP	Letter	2004/06/07	下载
020563	024	AP	Letter	2004/06/07	下载
020563	024	AP	Label	2004/06/07	下载
020563	016	AP	Letter	2004/06/07	下载
020563	015	AP	Label	2003/03/11	下载
020563	013	AP	Letter	2000/04/04	下载
020563	013	AP	Label	2000/04/04	下载
020563	012	AP	Letter	2000/04/04	下载
020563	012	AP	Label	2000/04/04	下载
020563	011	AP	Letter	2000/04/04	下载
020563	011	AP	Label	2000/04/04	下载
020563	010	AP	Letter	2000/04/04	下载
020563	010	AP	Label	2000/04/04	下载
020563	009	AP	Review	2007/07/09	下载
020563	003	AP	Review	1997/07/16	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
020563	171	AP	2016/10/17	Manufacturing Change or Addition
020563	170	AP	2016/09/22	Manufacturing Change or Addition
020563	163	AP	2015/06/12	Labeling Revision
020563	161	AP	2015/09/10	Manufacturing Change or Addition
020563	159	AP	2015/06/11	Manufacturing Change or Addition
020563	157	AP	2015/02/25	Labeling Revision
020563	156	AP	2015/01/26	Manufacturing Change or Addition
020563	155	AP	2014/11/11	Manufacturing Change or Addition
020563	152	AP	2014/09/12	Manufacturing Change or Addition
020563	150	AP	2014/06/04	Manufacturing Change or Addition
020563	149	AP	2014/04/11	Manufacturing Change or Addition
020563	148	AP	2014/04/03	Manufacturing Change or Addition
020563	147	AP	2014/04/01	Manufacturing Change or Addition
020563	146	AP	2014/01/24	Manufacturing Change or Addition
020563	145	AP	2014/03/18	Manufacturing Change or Addition
020563	144	AP	2014/03/04	Manufacturing Change or Addition
020563	143	AP	2014/01/31	Manufacturing Change or Addition
020563	142	AP	2013/08/15	Manufacturing Change or Addition
020563	141	AP	2013/07/18	Manufacturing Change or Addition
020563	139	AP	2013/08/21	Manufacturing Change or Addition
020563	137	AP	2013/03/28	Manufacturing Change or Addition
020563	135	AP	2013/03/14	Manufacturing Change or Addition
020563	134	AP	2013/05/10	Manufacturing Change or Addition
020563	133	AP	2013/09/06	Manufacturing Change or Addition
020563	132	AP	2013/02/15	Manufacturing Change or Addition
020563	131	AP	2013/06/12	Manufacturing Change or Addition
020563	127	AP	2013/01/30	Labeling Revision
020563	124	AP	2015/03/13	Labeling Revision
020563	123	AP	2012/10/12	New Route of Administration
020563	117	AP	2011/10/30	Labeling Revision
020563	115	AP	2013/03/11	Labeling Revision
020563	105	AP	2011/05/18	Patient Population Altered
020563	098	AP	2011/05/18	Labeling Revision
020563	091	AP	2009/03/16	Control Supplement
020563	082	AP	2007/07/20	Labeling Revision
020563	076	AP	2007/06/14	Labeling Revision
020563	075	AP	2007/09/06	Package Change
020563	065	AP	2007/08/22	Labeling Revision
020563	064	AP	2007/09/07	Labeling Revision
020563	060	AP	2005/11/09	Labeling Revision
020563	054	AP	2005/05/20	Labeling Revision
020563	051	AP	2014/07/31	Manufacturing Change or Addition
020563	046	AP	2004/04/21	Labeling Revision
020563	044	AP	2003/11/19	Manufacturing Change or Addition
020563	041	AP	2003/09/29	Manufacturing Change or Addition
020563	040	AP	2003/06/24	Labeling Revision
020563	036	AP	2004/01/16	Labeling Revision
020563	035	AP	2002/10/25	New or Modified Indication
020563	034	AP	2002/02/05	Control Supplement
020563	033	AP	2001/12/17	Control Supplement
020563	032	AP	2003/04/01	Labeling Revision
020563	030	AP	2001/05/11	Manufacturing Change or Addition
020563	029	AP	2001/03/26	Control Supplement
020563	028	AP	2000/09/11	Control Supplement
020563	027	AP	2003/03/12	Labeling Revision
020563	026	AP	2000/07/07	Manufacturing Change or Addition
020563	025	AP	2000/03/14	Control Supplement
020563	024	AP	2004/06/02	New Route of Administration
020563	023	AP	2000/05/23	Manufacturing Change or Addition
020563	021	AP	2000/02/25	Manufacturing Change or Addition
020563	020	AP	2000/01/11	Manufacturing Change or Addition
020563	017	AP	1999/05/12	Control Supplement
020563	016	AP	2003/01/02	Labeling Revision
020563	015	AP	1999/02/25	Manufacturing Change or Addition
020563	014	AP	1999/02/25	Control Supplement
020563	013	AP	2000/04/04	Efficacy Supplement with Clinical Data to Support
020563	012	AP	2000/04/04	New or Modified Indication
020563	011	AP	2000/04/04	Efficacy Supplement with Clinical Data to Support
020563	010	AP	2000/04/04	New Dosage Regimen
020563	009	AP	1998/09/04	Package Change
020563	006	AP	1998/08/06	Package Change
020563	005	AP	1997/04/29	Manufacturing Change or Addition
020563	004	AP	1998/02/20	Package Change
020563	003	AP	1997/07/16	Labeling Revision
020563	002	AP	1997/03/05	Manufacturing Change or Addition
020563	001	AP	1997/01/09	Labeling Revision
020563	000	AP	1996/06/14	Approval

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