LEUSTATIN(CLADRIBINE) - 美国FDA药品数据库

药品名称	LEUSTATIN
申请号	020229	产品号	001
活性成分	CLADRIBINE	市场状态	停止上市
剂型或给药途径	INJECTABLE;INJECTION	规格	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
治疗等效代码		参比药物	否
批准日期	1993/02/26	申请机构	JANSSEN PHARMACEUTICALS INC
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
无

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
020229	034	AP	2012/08/02	Labeling Revision
020229	030	AP	2006/06/29	Labeling Revision
020229	028	AP	2002/04/23	Control Supplement
020229	027	AP	2001/11/07	Control Supplement
020229	026	AP	2001/11/07	Manufacturing Change or Addition
020229	025	AP	2001/01/19	Control Supplement
020229	024	AP	2000/10/24	Control Supplement
020229	023	AP	2000/04/11	Manufacturing Change or Addition
020229	022	AP	2000/02/09	Manufacturing Change or Addition
020229	021	AP	2002/08/22	Labeling Revision
020229	020	AP	1998/07/14	Manufacturing Change or Addition
020229	019	AP	1998/07/14	Expiration Date Change
020229	018	AP	1998/02/18	Control Supplement
020229	017	AP	1998/02/26	Control Supplement
020229	016	AP	1998/02/09	Manufacturing Change or Addition
020229	015	AP	1997/12/29	Control Supplement
020229	014	AP	1997/12/03	Manufacturing Change or Addition
020229	013	AP	1997/09/18	Control Supplement
020229	012	AP	1997/07/28	Manufacturing Change or Addition
020229	011	AP	1997/07/24	Control Supplement
020229	010	AP	1997/07/24	Control Supplement
020229	009	AP	1997/07/24	Expiration Date Change
020229	008	AP	1997/04/18	Control Supplement
020229	007	AP	2002/08/20	Labeling Revision
020229	006	AP	1996/10/23	Control Supplement
020229	005	AP	1996/04/18	Control Supplement
020229	004	AP	2002/08/20	Labeling Revision
020229	003	AP	1994/03/16	Manufacturing Change or Addition
020229	002	AP	1994/09/01	Manufacturing Change or Addition
020229	001	AP	1993/07/28	Control Supplement
020229	000	AP	1993/02/26	Approval