GLUCOPHAGE(METFORMIN HYDROCHLORIDE) - 美国FDA药品数据库

药品名称	GLUCOPHAGE
申请号	020357	产品号	001
活性成分	METFORMIN HYDROCHLORIDE	市场状态	处方药
剂型或给药途径	TABLET;ORAL	规格	500MG
治疗等效代码	AB	参比药物	否
批准日期	1995/03/03	申请机构	BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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
020357	036	AP	2013/11/13	Manufacturing Change or Addition
020357	035	AP	2013/03/14	Manufacturing Change or Addition
020357	031	AP	2008/08/27	Labeling Revision
020357	030	AP	2006/11/01	Labeling Revision
020357	027	AP	2004/03/19	Labeling Revision
020357	026	AP	2004/03/19	Labeling Revision
020357	024	AP	2002/01/08	Labeling Revision
020357	022	AP	2001/02/08	Labeling Revision
020357	021	AP	2000/08/04	Manufacturing Change or Addition
020357	020	AP	2001/04/19	Efficacy Supplement with Clinical Data to Support
020357	019	AP	2000/12/15	Patient Population Altered
020357	018	AP	1999/06/07	Control Supplement
020357	017	AP	1999/09/22	Efficacy Supplement with Clinical Data to Support
020357	016	AP	1999/03/12	Manufacturing Change or Addition
020357	015	AP	1999/06/01	Manufacturing Change or Addition
020357	014	AP	1998/12/04	Control Supplement
020357	013	AP	1998/11/18	Manufacturing Change or Addition
020357	011	AP	1998/11/05	Formulation Revision
020357	010	AP	1998/10/22	New or Modified Indication
020357	009	AP	1998/07/02	Manufacturing Change or Addition
020357	008	AP	1998/02/10	Labeling Revision
020357	007	AP	1998/05/15	Manufacturing Change or Addition
020357	006	AP	1997/11/06	Labeling Revision
020357	005	AP	1997/06/06	Manufacturing Change or Addition
020357	004	AP	1996/07/26	Manufacturing Change or Addition
020357	003	AP	1996/04/30	Control Supplement
020357	002	AP	1995/09/13	Package Change
020357	000	AP	1995/03/03	Approval