VERELAN(VERAPAMIL HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	VERELAN
申请号	019614	产品号	001
活性成分	VERAPAMIL HYDROCHLORIDE	市场状态	处方药
剂型或给药途径	CAPSULE, EXTENDED RELEASE;ORAL	规格	120MG
治疗等效代码	AB	参比药物	否
批准日期	1990/05/29	申请机构	RECRO GAINESVILLE 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
4863742	2007/06/19			U-3	PDF格式

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
019614	050	AP	2014/10/09	Labeling Revision
019614	049	AP	2011/11/14	Labeling Revision
019614	045	AP	2010/03/30	Labeling Revision
019614	034	AP	2010/03/30	Labeling Revision
019614	032	AP	2000/11/29	Manufacturing Change or Addition
019614	031	AP	2000/07/27	Manufacturing Change or Addition
019614	030	AP	1999/12/13	Manufacturing Change or Addition
019614	028	AP	1999/07/02	Manufacturing Change or Addition
019614	027	AP	1999/06/05	Labeling Revision
019614	026	AP	1998/10/15	Manufacturing Change or Addition
019614	025	AP	1997/07/29	Labeling Revision
019614	024	AP	1998/07/14	Labeling Revision
019614	023	AP	1997/12/30	Control Supplement
019614	022	AP	1997/04/23	Manufacturing Change or Addition
019614	020	AP	1996/05/31	Manufacturing Change or Addition
019614	019	AP	1996/05/31	Manufacturing Change or Addition
019614	018	AP	1996/05/16	Manufacturing Change or Addition
019614	017	AP	1996/02/01	Manufacturing Change or Addition
019614	016	AP	1995/08/02	Expiration Date Change
019614	013	AP	1996/05/10	Formulation Revision
019614	012	AP	1993/11/08	Labeling Revision
019614	011	AP	1995/06/21	Labeling Revision
019614	010	AP	1994/03/30	Package Change
019614	009	AP	1993/12/06	Labeling Revision
019614	008	AP	1992/10/02	Labeling Revision
019614	007	AP	1992/10/02	Labeling Revision
019614	006	AP	1994/10/12	Labeling Revision
019614	005	AP	1991/09/13	Labeling Revision
019614	004	AP	1991/06/06	Labeling Revision
019614	003	AP	1992/01/09	Formulation Revision
019614	002	AP	1994/08/18	Expiration Date Change
019614	001	AP	1994/04/05	Control Supplement
019614	000	AP	1990/05/29	Approval