药品名称DIOVAN
申请号020665产品号002
活性成分VALSARTAN市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格160MG
治疗等效代码参比药物
批准日期1996/12/23申请机构NOVARTIS PHARMACEUTICALS CORP
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
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
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
020665038APLetter2015/07/28下载
020665038APLabel2015/07/30下载
020665037APLetter2014/09/26下载
020665037APLabel2014/09/26下载
020665035APLabel2014/03/19下载
020665035APLetter2014/03/19下载
020665034APLabel2014/03/19下载
020665034APLetter2014/03/19下载
020665033APLetter2013/10/30下载
020665033APLabel2013/10/31下载
020665016APLetter2002/08/14下载
020665016APLabel2002/08/14下载
020665016APReview2002/08/14下载
020665004APReview2003/08/08下载
020665000APReview2010/03/16下载
020665000APOther 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
020665038AP2015/07/27Labeling Revision
020665037AP2014/09/24Labeling Revision
020665036AP2015/02/16Manufacturing Change or Addition
020665035AP2014/03/17Labeling Revision
020665034AP2014/03/17Labeling Revision
020665033AP2013/10/29Labeling Revision
020665019AP2002/08/01Manufacturing Change or Addition
020665018AP2002/11/06Control Supplement
020665017AP2002/04/29Manufacturing Change or Addition
020665016AP2002/08/14New or Modified Indication
020665015AP2001/10/23Manufacturing Change or Addition
020665014AP2000/11/02Manufacturing Change or Addition
020665012AP2000/07/27Manufacturing Change or Addition
020665011AP2000/05/10Manufacturing Change or Addition
020665010AP2000/04/18Control Supplement
020665009AP2000/02/23Manufacturing Change or Addition
020665008AP1999/11/29Labeling Revision
020665007AP1999/12/03Manufacturing Change or Addition
020665006AP1999/04/28Package Change
020665005AP1999/02/18Manufacturing Change or Addition
020665004AP1998/11/27Labeling Revision
020665003AP1998/08/18Manufacturing Change or Addition
020665002AP1997/08/15Manufacturing Change or Addition
020665001AP1997/06/27Labeling Revision
020665000AP1996/12/23Approval