药品名称DIOVAN HCT
申请号020818产品号002
活性成分HYDROCHLOROTHIAZIDE; VALSARTAN市场状态处方药
剂型或给药途径TABLET;ORAL规格12.5MG;160MG
治疗等效代码AB参比药物
批准日期1998/03/06申请机构NOVARTIS PHARMACEUTICALS CORP
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
62941972017/06/18U-3PDF格式
6294197*PED2017/12/18PDF格式
历史专利信息
53995782012/03/21U-3PDF格式
5399578*PED2012/09/21PDF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
I-5672011/07/31
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
020818066APLabel2015/07/30下载
020818064APLetter2014/09/26下载
020818064APLabel2014/09/26下载
020818062APLabel2014/03/19下载
020818062APLetter2014/03/19下载
020818060APLetter2014/06/03下载
020818060APLabel2014/06/03下载
020818058APLetter2014/03/19下载
020818058APLabel2014/03/19下载
020818056APLabel2012/10/05下载
020818056APLetter2012/10/09下载
020818054APLetter2012/07/30下载
020818054APLabel2012/07/30下载
020818053APLetter2012/01/23下载
020818053APLabel2012/01/23下载
020818051APLetter2012/02/17下载
020818051APLabel2012/02/17下载
020818049APLabel2011/12/12下载
020818049APLetter2011/12/14下载
020818047APLetter2011/06/09下载
020818047APLabel2011/06/27下载
020818046APLabel2011/12/12下载
020818046APLetter2011/12/14下载
020818043APLetter2010/04/23下载
020818043APLabel2010/05/03下载
020818036APLetter2008/08/05下载
020818035APLetter2007/09/11下载
020818032APLabel2006/11/22下载
020818032APLetter2006/12/04下载
020818027APLetter2006/05/02下载
020818027APLabel2006/05/02下载
020818024APPatient Package Insert2005/07/08下载
020818024APLabel2005/07/15下载
020818024APLetter2005/07/15下载
020818016APLetter2004/06/02下载
020818016APReview2003/07/08下载
020818012APLetter2002/01/17下载
020818000APReview2003/08/08下载
020818000APLetter2004/06/02下载
020818000APLabel2004/06/02下载
020818000APOther Important Information from FDA2011/12/22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
020818068AP2016/08/01Manufacturing Change or Addition
020818067AP2015/11/13Manufacturing Change or Addition
020818066AP2015/07/27Labeling Revision
020818065AP2015/05/22Manufacturing Change or Addition
020818064AP2014/09/24Labeling Revision
020818062AP2014/03/17Labeling Revision
020818060AP2014/05/30Manufacturing Change or Addition
020818059AP2014/04/23Manufacturing Change or Addition
020818058AP2014/03/17Labeling Revision
020818056AP2012/10/04Labeling Revision
020818054AP2012/07/26Labeling Revision
020818053AP2012/01/18Labeling Revision
020818051AP2012/02/16Labeling Revision
020818049AP2011/12/12Labeling Revision
020818047AP2011/06/03Labeling Revision
020818046AP2011/12/12Labeling Revision
020818043AP2010/04/21Labeling Revision
020818036AP2008/07/31New or Modified Indication
020818035AP2007/09/06Labeling Revision
020818032AP2006/11/20Labeling Revision
020818027AP2006/04/28New Dosage Regimen
020818024AP2005/07/07Labeling Revision
020818016AP2003/01/15Efficacy Supplement with Clinical Data to Support
020818015AP2002/08/01Manufacturing Change or Addition
020818014AP2002/11/06Control Supplement
020818013AP2002/04/29Manufacturing Change or Addition
020818012AP2002/01/17Control Supplement
020818011AP2001/10/23Manufacturing Change or Addition
020818010AP2001/09/27Manufacturing Change or Addition
020818008AP2000/11/02Manufacturing Change or Addition
020818007AP2000/05/10Manufacturing Change or Addition
020818006AP2000/03/01Labeling Revision
020818005AP2000/04/18Control Supplement
020818004AP1999/06/16Labeling Revision
020818003AP1999/04/28Package Change
020818002AP1999/02/18Manufacturing Change or Addition
020818001AP1998/11/16Control Supplement
020818000AP1998/03/06Approval