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
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
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
020357031APLetter2008/08/28下载
020357031APLabel2008/08/29下载
020357030APLabel2006/11/06下载
020357030APLetter2006/11/06下载
020357027APLetter2004/03/24下载
020357026APLetter2004/03/24下载
020357024APLetter2002/01/08下载
020357020APLetter2001/04/23下载
020357020APReview2007/04/11下载
020357019APLabel2000/02/15下载
020357019APLetter2000/12/15下载
020357019APReview2000/12/15下载
020357017APReview1999/09/22下载
020357010APLetter1998/10/22下载
020357010APReview1998/10/22下载
020357006APReview1997/11/06下载
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
020357036AP2013/11/13Manufacturing Change or Addition
020357035AP2013/03/14Manufacturing Change or Addition
020357031AP2008/08/27Labeling Revision
020357030AP2006/11/01Labeling Revision
020357027AP2004/03/19Labeling Revision
020357026AP2004/03/19Labeling Revision
020357024AP2002/01/08Labeling Revision
020357022AP2001/02/08Labeling Revision
020357021AP2000/08/04Manufacturing Change or Addition
020357020AP2001/04/19Efficacy Supplement with Clinical Data to Support
020357019AP2000/12/15Patient Population Altered
020357018AP1999/06/07Control Supplement
020357017AP1999/09/22Efficacy Supplement with Clinical Data to Support
020357016AP1999/03/12Manufacturing Change or Addition
020357015AP1999/06/01Manufacturing Change or Addition
020357014AP1998/12/04Control Supplement
020357013AP1998/11/18Manufacturing Change or Addition
020357011AP1998/11/05Formulation Revision
020357010AP1998/10/22New or Modified Indication
020357009AP1998/07/02Manufacturing Change or Addition
020357008AP1998/02/10Labeling Revision
020357007AP1998/05/15Manufacturing Change or Addition
020357006AP1997/11/06Labeling Revision
020357005AP1997/06/06Manufacturing Change or Addition
020357004AP1996/07/26Manufacturing Change or Addition
020357003AP1996/04/30Control Supplement
020357002AP1995/09/13Package Change
020357000AP1995/03/03Approval