药品名称LOVAZA
申请号021654产品号001
活性成分OMEGA-3-ACID ETHYL ESTERS市场状态处方药
剂型或给药途径CAPSULE;ORAL规格1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
治疗等效代码AB参比药物
批准日期2004/11/10申请机构SMITHKLINE BEECHAM
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
55020772013/03/26YU-822PDF格式
56566672017/04/10YYU-822PDF格式
56566672018/08/27YYU-822PDF格式
56985942009/08/04YU-822PDF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
M-642010/06/12
NCE2009/11/10
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
021654041APLabel2014/05/14下载
021654041APLetter2014/05/14下载
021654039APLabel2013/09/17下载
021654037APLetter2013/06/27下载
021654037APLabel2013/07/08下载
021654034APLetter2012/09/06下载
021654034APLabel2012/09/06下载
021654033APLetter2011/09/21下载
021654030APLabel2010/12/26下载
021654030APLetter2010/12/28下载
021654023APLetter2009/04/21下载
021654023APLabel2009/04/23下载
021654022APLabel2009/09/21下载
021654022APLetter2009/11/10下载
021654021APLetter2008/06/06下载
021654021APLabel2008/06/19下载
021654018APReview2011/12/14下载
021654016APReview2009/11/19下载
021654016APLetter2007/07/05下载
021654015APLetter2008/01/09下载
021654014APPatient Information Sheet2007/11/07下载
021654014APLetter2007/11/08下载
021654007APLetter2006/07/13下载
021654004APLabel2007/02/02下载
021654004APLetter2007/02/12下载
021654000APLetter2004/11/16下载
021654000APLabel2004/11/16下载
021654000APReview2005/01/11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
021654042AP2015/03/09Manufacturing Change or Addition
021654041AP2014/05/14Labeling Revision
021654040AP2014/06/05Manufacturing Change or Addition
021654039AP2013/09/11Manufacturing Change or Addition
021654038AP2013/11/15Manufacturing Change or Addition
021654037AP2013/06/26Labeling Revision
021654034AP2012/09/04Labeling Revision
021654033AP2011/09/19Labeling Revision
021654031AP2011/08/11Labeling Revision
021654030AP2010/12/22Labeling Revision
021654023AP2009/04/20Labeling Revision
021654022AP2009/09/16Efficacy Supplement with Clinical Data to Support
021654021AP2008/06/03Labeling Revision
021654018AP2008/01/24Manufacturing Change or Addition
021654016AP2007/06/12Labeling Revision
021654015AP2007/12/06Manufacturing Change or Addition
021654014AP2007/11/07Labeling Revision
021654007AP2006/07/03Manufacturing Change or Addition
021654004AP2007/02/01Labeling Revision
021654000AP2004/11/10Approval