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

药品名称	SAIZEN
申请号	019764	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	1996/10/08	申请机构	EMD SERONO INC
化学类型	New formulation or new manufacturer	审评分类	Standard 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
I-440	2007/08/26

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
019764	072	AP	Label	2014/06/17	下载
019764	072	AP	Letter	2014/06/18	下载
019764	049	AP	Letter	2012/04/05	下载
019764	049	AP	Label	2012/04/06	下载
019764	039	AP	Label	2007/08/30	下载
019764	039	AP	Letter	2007/08/30	下载
019764	037	AP	Label	2007/08/23	下载
019764	037	AP	Letter	2007/08/27	下载
019764	035	AP	Label	2007/11/07	下载
019764	035	AP	Letter	2007/11/08	下载
019764	034	AP	Label	2007/03/07	下载
019764	034	AP	Letter	2007/03/15	下载
019764	030	AP	Label	2007/01/18	下载
019764	030	AP	Letter	2007/01/25	下载
019764	025	AP	Letter	2004/07/14	下载
019764	025	AP	Label	2004/07/14	下载
019764	023	AP	Label	2003/07/08	下载
019764	023	AP	Letter	2003/07/08	下载
019764	020	AP	Letter	2004/11/15	下载
019764	020	AP	Label	2004/11/15	下载
019764	011	AP	Review	2009/01/12	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
019764	082	AP	2016/09/07	Manufacturing Change or Addition
019764	080	AP	2016/04/21	Manufacturing Change or Addition
019764	078	AP	2015/06/12	Manufacturing Change or Addition
019764	077	AP	2015/03/03	Manufacturing Change or Addition
019764	076	AP	2015/02/16	Manufacturing Change or Addition
019764	074	AP	2014/08/11	Manufacturing Change or Addition
019764	073	AP	2014/09/30	Manufacturing Change or Addition
019764	072	AP	2014/06/16	Labeling Revision
019764	071	AP	2013/11/18	Manufacturing Change or Addition
019764	070	AP	2013/12/12	Manufacturing Change or Addition
019764	069	AP	2013/04/05	Manufacturing Change or Addition
019764	067	AP	2013/02/20	Manufacturing Change or Addition
019764	066	AP	2013/02/15	Manufacturing Change or Addition
019764	065	AP	2013/02/15	Manufacturing Change or Addition
019764	064	AP	2013/01/31	Manufacturing Change or Addition
019764	063	AP	2013/02/13	Manufacturing Change or Addition
019764	062	AP	2015/06/11	Manufacturing Change or Addition
019764	061	AP	2013/02/08	Manufacturing Change or Addition
019764	060	AP	2013/02/07	Manufacturing Change or Addition
019764	059	AP	2013/11/13	Manufacturing Change or Addition
019764	058	AP	2013/01/19	Manufacturing Change or Addition
019764	057	AP	2013/01/19	Manufacturing Change or Addition
019764	056	AP	2013/01/19	Manufacturing Change or Addition
019764	054	AP	2013/01/18	Manufacturing Change or Addition
019764	053	AP	2013/01/11	Manufacturing Change or Addition
019764	052	AP	2013/01/11	Manufacturing Change or Addition
019764	049	AP	2012/04/03	Labeling Revision
019764	039	AP	2007/08/27	Labeling Revision
019764	037	AP	2007/08/22	Labeling Revision
019764	035	AP	2007/10/31	Package Change
019764	034	AP	2007/03/05	Labeling Revision
019764	030	AP	2007/01/16	Control Supplement
019764	025	AP	2004/07/09	Package Change
019764	023	AP	2003/07/01	Labeling Revision
019764	020	AP	2004/11/01	New or Modified Indication
019764	019	AP	2002/10/17	Control Supplement
019764	018	AP	2002/12/31	Manufacturing Change or Addition
019764	017	AP	2002/12/20	Manufacturing Change or Addition
019764	016	AP	2001/12/03	Control Supplement
019764	015	AP	2002/09/06	Control Supplement
019764	014	AP	2001/07/19	Manufacturing Change or Addition
019764	013	AP	2001/05/03	Manufacturing Change or Addition
019764	012	AP	2000/08/17	Control Supplement
019764	011	AP	2000/07/19	Control Supplement
019764	010	AP	2000/04/11	Manufacturing Change or Addition
019764	009	AP	2000/07/26	Labeling Revision
019764	008	AP	2000/06/07	Manufacturing Change or Addition
019764	007	AP	2000/03/28	Manufacturing Change or Addition
019764	006	AP	2000/04/04	Labeling Revision
019764	005	AP	1999/02/11	Manufacturing Change or Addition
019764	004	AP	1998/07/09	Manufacturing Change or Addition
019764	003	AP	2000/08/29	Control Supplement
019764	002	AP	1998/01/21	Manufacturing Change or Addition
019764	001	AP	1996/12/09	Labeling Revision
019764	000	AP	1996/10/08	Approval

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