药品名称KEPPRA
申请号021035产品号004
活性成分LEVETIRACETAM市场状态处方药
剂型或给药途径TABLET;ORAL规格1GM
治疗等效代码AB参比药物
批准日期2006/01/06申请机构UCB INC
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
88021422031/06/07YPDF格式
8802142*PED2031/12/07PDF格式
历史专利信息
49436392008/07/14YPDF格式
4943639*PED2009/01/14PDF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-5062009/08/15
I-5272010/03/19
NPP2008/06/21
NPP2014/12/16
PED2008/12/21
PED2010/02/15
PED2010/09/19
PED2015/06/16
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
021035096APLetter2016/10/28下载
021035094APLabel2014/08/08下载
021035094APLetter2014/08/11下载
021035093APLetter2015/03/12下载
021035093APLabel2015/03/12下载
021035091APLabel2014/03/10下载
021035091APLetter2014/03/11下载
021035090APLetter2011/08/12下载
021035089APLetter2013/07/26下载
021035089APLabel2013/07/30下载
021035085APMedication Guide2011/12/20下载
021035085APLetter2011/12/21下载
021035085APLabel2011/12/20下载
021035083APLabel2011/12/20下载
021035083APMedication Guide2011/12/20下载
021035083APLetter2011/12/21下载
021035080APLetter2009/05/04下载
021035080APLabel2009/05/13下载
021035078APLabel2009/05/13下载
021035078APLetter2009/05/04下载
021035074APLabel2011/12/20下载
021035074APLetter2011/12/21下载
021035074APMedication Guide2011/12/20下载
021035073APMedication Guide2011/12/20下载
021035073APLetter2011/12/21下载
021035073APLabel2011/12/20下载
021035062APLetter2007/09/25下载
021035057APLetter2007/03/23下载
021035057APLabel2007/03/23下载
021035054APLetter2006/08/18下载
021035054APLabel2006/08/18下载
021035052APLabel2011/12/20下载
021035052APMedication Guide2011/12/20下载
021035052APLetter2011/12/21下载
021035050APLetter2006/08/18下载
021035050APLabel2006/08/18下载
021035048APLetter2006/01/20下载
021035040APLetter2005/06/23下载
021035040APLabel2005/06/23下载
021035038APLetter2006/01/30下载
021035033APLetter2004/10/29下载
021035032APLetter2004/10/29下载
021035030APLetter2003/09/09下载
021035019APLetter2002/05/22下载
021035013APLetter2002/05/22下载
021035000APOther Important Information from FDA2007/03/28下载
021035000APLetter1999/11/30下载
021035000APLabel1999/11/30下载
021035000APReview1999/11/30下载
021035000APMedication Guide2009/09/30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
021035097AP2016/09/13Manufacturing Change or Addition
021035096AP2016/10/26Labeling Revision
021035095AP2016/02/04Manufacturing Change or Addition
021035094AP2014/08/07Labeling Revision
021035093AP2015/03/10Labeling Revision
021035092AP2012/11/13Manufacturing Change or Addition
021035091AP2014/03/07Labeling Revision
021035090AP2011/08/10Labeling Revision
021035089AP2013/07/25Labeling Revision
021035085AP2011/12/16Labeling Revision
021035083AP2011/12/16Labeling Revision
021035080AP2009/04/23Labeling Revision
021035078AP2009/04/23Labeling Revision
021035074AP2011/12/16Labeling Revision
021035073AP2011/12/16Efficacy Supplement with Clinical Data to Support
021035062AP2007/09/12Labeling Revision
021035057AP2007/03/19New or Modified Indication
021035054AP2006/08/15Labeling Revision
021035052AP2011/12/16Labeling Revision
021035050AP2006/08/15New or Modified Indication
021035048AP2006/01/06Formulation Revision
021035040AP2005/06/21Patient Population Altered
021035038AP2006/01/24Labeling Revision
021035033AP2004/10/26Labeling Revision
021035032AP2004/10/26Labeling Revision
021035030AP2003/09/03Labeling Revision
021035022AP2002/10/17Control Supplement
021035021AP2002/04/17Control Supplement
021035020AP2002/04/01Control Supplement
021035019AP2002/05/22Labeling Revision
021035018AP2002/05/07Manufacturing Change or Addition
021035017AP2002/01/04Manufacturing Change or Addition
021035016AP2002/01/04Manufacturing Change or Addition
021035015AP2001/10/24Control Supplement
021035014AP2001/11/27Manufacturing Change or Addition
021035013AP2002/05/22Labeling Revision
021035012AP2001/11/27Manufacturing Change or Addition
021035011AP2001/04/26Manufacturing Change or Addition
021035010AP2001/07/05Control Supplement
021035009AP2000/12/04Control Supplement
021035008AP2000/12/04Control Supplement
021035007AP2000/10/04Manufacturing Change or Addition
021035006AP2000/08/09Manufacturing Change or Addition
021035005AP2000/07/27Manufacturing Change or Addition
021035004AP2000/05/15Manufacturing Change or Addition
021035003AP2000/04/10Labeling Revision
021035000AP1999/11/30Approval