CEREZYME(IMIGLUCERASE) - 美国FDA药品数据库

药品名称	CEREZYME
申请号	020367	产品号	002
活性成分	IMIGLUCERASE	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	400 UNITS/VIAL
治疗等效代码		参比药物	是
批准日期	1999/09/22	申请机构	GENZYME CORP
化学类型	New molecular entity (NME)	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
无
历史专利信息
5549892	2013/08/27			U-252	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
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
020367	066	AP	Letter	2005/03/10	下载
020367	066	AP	Label	2005/03/10	下载
020367	055	AP	Label	2002/11/13	下载
020367	055	AP	Letter	2003/07/31	下载
020367	053	AP	Letter	2002/06/14	下载
020367	053	AP	Label	2002/06/14	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
020367	102	AP	2016/09/30	Manufacturing Change or Addition
020367	101	AP	2016/07/22	Manufacturing Change or Addition
020367	100	AP	2016/09/14	Manufacturing Change or Addition
020367	099	AP	2016/07/07	Manufacturing Change or Addition
020367	098	AP	2016/06/08	Manufacturing Change or Addition
020367	097	AP	2016/04/21	Manufacturing Change or Addition
020367	096	AP	2016/03/03	Manufacturing Change or Addition
020367	095	AP	2015/10/30	Manufacturing Change or Addition
020367	094	AP	2015/08/10	Manufacturing Change or Addition
020367	092	AP	2015/03/09	Manufacturing Change or Addition
020367	091	AP	2014/09/05	Manufacturing Change or Addition
020367	090	AP	2014/02/27	Manufacturing Change or Addition
020367	089	AP	2013/10/30	Manufacturing Change or Addition
020367	088	AP	2013/07/31	Manufacturing Change or Addition
020367	066	AP	2005/03/03	Manufacturing Change or Addition
020367	056	AP	2002/10/09	Manufacturing Change or Addition
020367	055	AP	2002/11/13	Labeling Revision
020367	053	AP	2002/06/14	Labeling Revision
020367	051	AP	2001/05/08	Manufacturing Change or Addition
020367	050	AP	2001/05/07	Control Supplement
020367	049	AP	2001/08/13	Labeling Revision
020367	048	AP	2000/11/14	Control Supplement
020367	047	AP	2000/10/27	Control Supplement
020367	046	AP	2000/08/31	Control Supplement
020367	045	AP	2000/09/11	Control Supplement
020367	044	AP	2000/07/10	Control Supplement
020367	043	AP	2000/04/10	Manufacturing Change or Addition
020367	042	AP	2001/08/13	Labeling Revision
020367	041	AP	2001/08/13	Labeling Revision
020367	040	AP	1999/12/08	Manufacturing Change or Addition
020367	039	AP	1999/09/07	Control Supplement
020367	038	AP	1999/10/22	Control Supplement
020367	037	AP	1999/10/05	Control Supplement
020367	036	AP	1999/07/28	Control Supplement
020367	035	AP	1999/07/26	Package Change
020367	034	AP	1999/09/22	Formulation Revision
020367	033	AP	1999/01/04	Control Supplement
020367	032	AP	1998/11/18	Control Supplement
020367	031	AP	1998/06/17	Control Supplement
020367	030	AP	1998/06/12	Control Supplement
020367	029	AP	1998/06/12	Control Supplement
020367	028	AP	1998/03/23	Control Supplement
020367	027	AP	1999/02/11	Labeling Revision
020367	026	AP	1998/01/30	Control Supplement
020367	025	AP	1997/08/08	Control Supplement
020367	024	AP	1997/07/31	Manufacturing Change or Addition
020367	023	AP	1997/07/16	Control Supplement
020367	021	AP	1996/12/20	Control Supplement
020367	020	AP	1997/03/03	Control Supplement
020367	018	AP	1996/09/23	Control Supplement
020367	017	AP	1996/12/12	Control Supplement
020367	016	AP	1996/10/22	Manufacturing Change or Addition
020367	015	AP	1996/09/20	Manufacturing Change or Addition
020367	013	AP	1996/06/05	Manufacturing Change or Addition
020367	012	AP	1996/04/08	Control Supplement
020367	011	AP	1996/02/23	Control Supplement
020367	010	AP	1996/05/31	Control Supplement
020367	009	AP	1995/12/06	Control Supplement
020367	008	AP	1996/04/18	Manufacturing Change or Addition
020367	007	AP	1995/07/24	Control Supplement
020367	006	AP	1997/12/07	Labeling Revision
020367	005	AP	1995/05/03	Control Supplement
020367	004	AP	1995/05/08	Formulation Revision
020367	003	AP	1995/02/07	Manufacturing Change or Addition
020367	002	AP	1995/06/19	Manufacturing Change or Addition
020367	001	AP	1995/04/07	Control Supplement
020367	000	AP	1994/05/23	Approval

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