药品名称ZIAC
申请号020186产品号001
活性成分BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格5MG;6.25MG
治疗等效代码AB参比药物
批准日期1993/03/26申请机构TEVA WOMENS HEALTH INC
化学类型New combination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
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
020186027APLabel2011/05/05下载
020186026APLabel2009/11/19下载
020186026APLetter2010/01/19下载
020186023APLabel2010/08/12下载
020186023APLetter2007/09/26下载
020186015APLetter2004/07/01下载
020186004APReview2001/08/01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
020186032AP2015/07/27Manufacturing Change or Addition
020186031AP2014/06/12Manufacturing Change or Addition
020186030AP2013/12/12Manufacturing Change or Addition
020186028AP2011/05/03Labeling Revision
020186027AP2011/05/03Labeling Revision
020186026AP2009/11/06Labeling Revision
020186023AP2007/09/25Labeling Revision
020186015AP2003/01/24Labeling Revision
020186011AP2000/04/04Labeling Revision
020186010AP1999/06/22Control Supplement
020186009AP1999/02/16Manufacturing Change or Addition
020186008AP1998/04/01Labeling Revision
020186007AP1998/01/15Package Change
020186006AP1996/10/09Control Supplement
020186005AP1996/04/24Labeling Revision
020186004AP1995/05/30Labeling Revision
020186003AP1994/04/15Control Supplement
020186002AP1993/11/24Control Supplement
020186001AP1993/09/07Expiration Date Change
020186000AP1993/03/26Approval