SEROSTIM(SOMATROPIN RECOMBINANT) - 美国FDA药品数据库

药品名称	SEROSTIM
申请号	020604	产品号	002
活性成分	SOMATROPIN RECOMBINANT	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	5MG/VIAL
治疗等效代码	BX	参比药物	否
批准日期	1996/08/23	申请机构	EMD SERONO INC
化学类型	New formulation or new manufacturer	审评分类	Priority review drug
罕用药/孤儿药	是

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
5898030	2016/04/27		Y		PDF格式
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
M-65	2010/07/13

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
020604	078	AP	Letter	2014/06/19	下载
020604	078	AP	Label	2014/06/23	下载
020604	049	AP	Letter	2012/04/05	下载
020604	049	AP	Label	2012/04/06	下载
020604	048	AP	Letter	2009/11/19	下载
020604	044	AP	Label	2007/08/30	下载
020604	044	AP	Letter	2007/08/30	下载
020604	044	AP	Label	2007/09/04	下载
020604	044	AP	Letter	2007/09/04	下载
020604	040	AP	Review	2011/02/15	下载
020604	040	AP	Label	2007/07/16	下载
020604	040	AP	Letter	2007/07/24	下载
020604	035	AP	Label	2006/12/04	下载
020604	035	AP	Letter	2006/12/04	下载
020604	034	AP	Letter	2006/09/25	下载
020604	034	AP	Label	2006/09/25	下载
020604	031	AP	Letter	2005/08/31	下载
020604	031	AP	Label	2005/08/31	下载
020604	030	AP	Letter	2004/07/14	下载
020604	030	AP	Label	2004/07/14	下载
020604	029	AP	Letter	2005/02/17	下载
020604	029	AP	Label	2005/02/17	下载
020604	027	AP	Label	2003/09/09	下载
020604	027	AP	Letter	2003/09/09	下载
020604	027	AP	Review	2009/09/16	下载
020604	026	AP	Letter	2003/12/04	下载
020604	026	AP	Label	2003/12/08	下载
020604	026	AP	Review	2007/08/06	下载
020604	012	AP	Review	2009/09/16	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
020604	082	AP	2014/08/11	Manufacturing Change or Addition
020604	081	AP	2014/09/30	Manufacturing Change or Addition
020604	080	AP	2014/09/17	Manufacturing Change or Addition
020604	078	AP	2014/06/16	Labeling Revision
020604	076	AP	2013/12/12	Manufacturing Change or Addition
020604	075	AP	2013/12/11	Manufacturing Change or Addition
020604	073	AP	2013/04/05	Manufacturing Change or Addition
020604	071	AP	2013/02/28	Manufacturing Change or Addition
020604	071	AP	2013/12/17	Manufacturing Change or Addition
020604	068	AP	2013/02/15	Manufacturing Change or Addition
020604	067	AP	2013/01/31	Manufacturing Change or Addition
020604	065	AP	2013/02/08	Manufacturing Change or Addition
020604	058	AP	2012/11/20	Manufacturing Change or Addition
020604	049	AP	2012/04/03	Labeling Revision
020604	048	AP	2009/08/31	Labeling Revision
020604	044	AP	2007/08/27	Labeling Revision
020604	044	AP	2007/08/30	Labeling Revision
020604	040	AP	2007/07/13	Labeling Revision
020604	035	AP	2006/11/27	Control Supplement
020604	034	AP	2006/09/21	Control Supplement
020604	031	AP	2005/08/24	Labeling Revision
020604	030	AP	2004/07/09	Package Change
020604	029	AP	2005/02/11	Formulation Revision
020604	027	AP	2003/08/29	Accelerated Approval
020604	026	AP	2003/12/01	Labeling Revision
020604	023	AP	2002/10/17	Control Supplement
020604	022	AP	2002/12/31	Manufacturing Change or Addition
020604	021	AP	2002/12/20	Manufacturing Change or Addition
020604	020	AP	2001/12/03	Control Supplement
020604	019	AP	2001/11/19	Control Supplement
020604	018	AP	2002/09/06	Control Supplement
020604	017	AP	2001/07/19	Manufacturing Change or Addition
020604	016	AP	2001/09/06	Labeling Revision
020604	015	AP	2001/05/03	Manufacturing Change or Addition
020604	014	AP	2001/06/13	Labeling Revision
020604	013	AP	2000/08/17	Control Supplement
020604	012	AP	2000/07/19	Control Supplement
020604	011	AP	2000/04/11	Manufacturing Change or Addition
020604	010	AP	2000/10/27	Labeling Revision
020604	009	AP	2000/07/17	Labeling Revision
020604	008	AP	2000/09/18	Expiration Date Change
020604	007	AP	2000/03/28	Manufacturing Change or Addition
020604	006	AP	2000/04/04	Labeling Revision
020604	005	AP	1998/07/09	Control Supplement
020604	004	AP	1998/07/09	Manufacturing Change or Addition
020604	003	AP	1998/01/21	Manufacturing Change or Addition
020604	002	AP	1997/07/25	Control Supplement
020604	001	AP	1998/01/16	Labeling Revision
020604	000	AP	1996/08/23	Approval

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