NORPACE CR(DISOPYRAMIDE PHOSPHATE) - 美国FDA药品数据库

药品名称	NORPACE CR
申请号	018655	产品号	002
活性成分	DISOPYRAMIDE PHOSPHATE	市场状态	处方药
剂型或给药途径	CAPSULE, EXTENDED RELEASE;ORAL	规格	EQ 150MG BASE
治疗等效代码	AB	参比药物	是
批准日期	1982/07/20	申请机构	GD SEARLE LLC
化学类型	New dosage form	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
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
018655	033	AP	2000/05/17	Labeling Revision
018655	032	AP	1998/11/10	Labeling Revision
018655	031	AP	1998/07/17	Control Supplement
018655	030	AP	1998/02/03	Labeling Revision
018655	029	AP	1997/01/13	Manufacturing Change or Addition
018655	028	AP	1996/06/28	Labeling Revision
018655	027	AP	1993/12/21	Package Change
018655	026	AP	1991/07/03	New or Modified Indication
018655	025	AP	1992/01/16	Labeling Revision
018655	024	AP	1989/11/16	Labeling Revision
018655	023	AP	1989/10/20	Labeling Revision
018655	022	AP	1988/02/04	Manufacturing Change or Addition
018655	021	AP	1987/08/28	Labeling Revision
018655	020	AP	1987/06/30	Manufacturing Change or Addition
018655	019	AP	1987/02/12	Labeling Revision
018655	018	AP	1987/04/21	Manufacturing Change or Addition
018655	016	AP	1986/05/30	Labeling Revision
018655	015	AP	1986/05/06	Manufacturing Change or Addition
018655	014	AP	1985/11/26	Expiration Date Change
018655	013	AP	1985/06/18	Labeling Revision
018655	012	AP	1985/01/25	Manufacturing Change or Addition
018655	011	AP	1985/06/19	Labeling Revision
018655	010	AP	1984/02/29	Labeling Revision
018655	009	AP	1983/10/19	Labeling Revision
018655	008	AP	1985/06/19	General Efficacy (MarkIV)
018655	007	AP	1983/09/06	Control Supplement
018655	006	AP	1983/03/10	Package Change
018655	005	AP	1983/06/10	Manufacturing Change or Addition
018655	004	AP	1985/06/19	Labeling Revision
018655	002	AP	1982/09/22	Control Supplement
018655	001	AP	1982/09/21	Labeling Revision
018655	000	AP	1982/07/20	Approval