PRONESTYL(PROCAINAMIDE HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	PRONESTYL
申请号	007335	产品号	003
活性成分	PROCAINAMIDE HYDROCHLORIDE	市场状态	停止上市
剂型或给药途径	CAPSULE;ORAL	规格	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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	Approved Prior to Jan 1, 1982	申请机构	APOTHECON INC DIV BRISTOL MYERS SQUIBB
化学类型	New molecular entity (NME)	审评分类	Priority 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
007335	061	AP	1997/05/06	Labeling Revision
007335	060	AP	1995/09/12	Manufacturing Change or Addition
007335	059	AP	1992/06/08	Manufacturing Change or Addition
007335	058	AP	1991/10/03	New or Modified Indication
007335	057	AP	1989/12/22	Package Change
007335	056	AP	1989/03/30	Labeling Revision
007335	055	AP	1987/10/09	Control Supplement
007335	054	AP	1987/06/12	Labeling Revision
007335	053	AP	1989/03/30	Labeling Revision
007335	052	AP	1986/05/20	Control Supplement
007335	051	AP	1984/05/07	Formulation Revision
007335	050	AP	1983/10/12	Expiration Date Change
007335	049	AP	1985/05/29	Formulation Revision
007335	048	AP	1983/05/04	Control Supplement
007335	047	AP	1982/12/15	Control Supplement
007335	046	AP	1982/09/22	Manufacturing Change or Addition
007335	045	AP	1985/05/09	Practioner Draft Labeling
007335	044	AP	1981/01/27	Package Change
007335	043	AP	1985/05/09	Practioner Draft Labeling
007335	042	AP	1980/04/28	Formulation Revision
007335	041	AP	1979/03/06	Control Supplement
007335	040	AP	1979/04/05	Labeling Revision
007335	039	AP	1978/06/30	Expiration Date Change
007335	038	AP	1978/06/07	Control Supplement
007335	037	AP	1978/06/07	Formulation Revision
007335	036	AP	1977/10/21	Control Supplement
007335	035	AP	1977/10/21	Control Supplement
007335	034	AP	1977/09/14	Control Supplement
007335	032	AP	1977/09/14	Package Change
007335	030	AP	1978/08/10	Labeling Revision
007335	029	AP	1976/09/08	Package Change
007335	023	AP	1976/09/08	Other Amendment
007335	000	AP	1950/06/02	Approval