药品名称DEMADEX
申请号020136产品号003
活性成分TORSEMIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格20MG
治疗等效代码AB参比药物
批准日期1993/08/23申请机构MEDA PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
历史专利信息
RE346722006/08/11PDF格式
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
020136024APLetter2012/08/15下载
020136024APLabel2012/08/15下载
020136023APLabel2010/01/29下载
020136023APLetter2010/02/01下载
020136009APReview1997/10/09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
020136026AP2013/11/22Manufacturing Change or Addition
020136025AP2012/11/16Manufacturing Change or Addition
020136024AP2012/08/14Labeling Revision
020136023AP2010/01/27Labeling Revision
020136019AP2002/09/17Package Change
020136017AP1998/04/20Manufacturing Change or Addition
020136016AP1998/03/16Manufacturing Change or Addition
020136015AP1998/01/07Control Supplement
020136014AP1997/11/26Manufacturing Change or Addition
020136013AP1997/10/01Control Supplement
020136012AP1997/05/30Control Supplement
020136011AP1998/02/13Labeling Revision
020136010AP1996/10/30Control Supplement
020136009AP1997/09/09New or Modified Indication
020136008AP1995/11/30Control Supplement
020136007AP1995/11/01Control Supplement
020136006AP1995/10/24Control Supplement
020136005AP1995/11/15Manufacturing Change or Addition
020136004AP1996/02/14Manufacturing Change or Addition
020136003AP1995/05/12Control Supplement
020136002AP1995/08/09Manufacturing Change or Addition
020136001AP1995/09/05Labeling Revision
020136000AP1993/08/23Approval