药品名称DIOVAN
申请号021283产品号001
活性成分VALSARTAN市场状态处方药
剂型或给药途径TABLET;ORAL规格80MG
治疗等效代码AB参比药物
批准日期2001/07/18申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New dosage form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
59729902016/10/26U-692PDF格式
62941972017/06/18U-3PDF格式
5972990*PED2017/04/26PDF格式
6294197*PED2017/12/18PDF格式
历史专利信息
53995782012/03/21PDF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-4632008/08/03
I-5502010/11/29
PED2009/02/03
PED2011/05/29
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
021283046APLetter2015/07/28下载
021283046APLabel2015/07/30下载
021283044APLabel2014/09/30下载
021283044APLetter2014/10/01下载
021283042APLetter2014/03/19下载
021283042APLabel2014/03/19下载
021283041APLabel2014/03/19下载
021283041APLetter2014/03/19下载
021283039APLabel2012/10/05下载
021283039APLetter2012/10/09下载
021283037APLetter2012/07/30下载
021283037APLabel2012/07/30下载
021283036APLetter2012/01/23下载
021283036APLabel2012/01/23下载
021283035APLetter2012/02/29下载
021283035APLabel2012/03/06下载
021283033APLabel2011/12/12下载
021283033APLetter2011/12/14下载
021283032APLabel2011/06/07下载
021283032APLetter2011/06/07下载
021283027APLetter2009/06/17下载
021283027APLabel2009/06/22下载
021283024APReview2012/03/02下载
021283024APLabel2007/12/03下载
021283024APLetter2008/01/09下载
021283021APLetter2007/08/22下载
021283021APReview2012/03/02下载
021283018APLabel2006/12/04下载
021283018APLetter2006/12/04下载
021283012APLabel2004/12/03下载
021283012APLetter2004/12/06下载
021283011APLetter2005/08/08下载
021283011APLabel2005/08/08下载
021283011APReview2007/03/31下载
021283004APReview2006/06/06下载
021283004APLabel2006/06/06下载
021283002APLetter2002/04/05下载
021283002APLabel2002/04/05下载
021283002APReview2002/04/05下载
021283001APReview2002/08/14下载
021283001APLetter2002/08/14下载
021283001APLabel2002/08/14下载
021283000APReview2007/06/22下载
021283000APLabel2003/05/05下载
021283000APOther 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
021283049AP2016/10/12Manufacturing Change or Addition
021283047AP2015/07/31Manufacturing Change or Addition
021283046AP2015/07/27Labeling Revision
021283044AP2014/09/26Labeling Revision
021283042AP2014/03/17Labeling Revision
021283041AP2014/03/17Labeling Revision
021283040AP2013/10/18Manufacturing Change or Addition
021283039AP2012/10/04Labeling Revision
021283037AP2012/07/26Labeling Revision
021283036AP2012/01/18Labeling Revision
021283035AP2012/02/28Labeling Revision
021283033AP2011/12/12Labeling Revision
021283032AP2011/06/03Labeling Revision
021283027AP2009/06/15Labeling Revision
021283024AP2007/11/29Patient Population Altered
021283021AP2007/08/17Labeling Revision
021283018AP2006/11/22Labeling Revision
021283012AP2004/11/30Labeling Revision
021283011AP2005/08/03New or Modified Indication
021283006AP2002/08/01Manufacturing Change or Addition
021283005AP2002/09/13Manufacturing Change or Addition
021283004AP2002/11/06Control Supplement
021283003AP2002/04/29Manufacturing Change or Addition
021283002AP2002/04/05Efficacy Supplement with Clinical Data to Support
021283001AP2002/08/14New or Modified Indication
021283000AP2001/07/18Approval