药品名称CHILDREN'S ALLEGRA HIVES
申请号020872产品号006
活性成分FEXOFENADINE HYDROCHLORIDE市场状态非处方药
剂型或给药途径TABLET;ORAL规格30MG
治疗等效代码参比药物
批准日期2011/01/24申请机构SANOFI AVENTIS US LLC
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
60373532017/03/14U-1160PDF格式
5855912*PED2015/08/28PDF格式
5932247*PED2015/08/28PDF格式
6037353*PED2017/09/14PDF格式
6113942*PED2015/08/28PDF格式
历史专利信息
55786102013/11/26YYU-1160PDF格式
5578610*PED2014/05/26PDF格式
58559122015/02/28YPDF格式
59322472015/02/28YPDF格式
61139422015/02/28YPDF格式
71355712014/05/18YU-1160PDF格式
7135571*PED2014/11/18PDF格式
71385242014/05/18YPDF格式
7138524*PED2014/11/18PDF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
020872038APLetter2016/05/12下载
020872038APLabel2016/05/12下载
020872032APLetter2014/09/16下载
020872032APLabel2014/09/23下载
020872031APLetter2014/04/17下载
020872031APLabel2014/08/06下载
020872029APLetter2012/08/27下载
020872029APLabel2012/11/13下载
020872025APLetter2012/02/27下载
020872025APLabel2012/03/27下载
020872023APLabel2013/11/26下载
020872023APLetter2011/01/27下载
020872018APLetter2008/06/30下载
020872018APLabel2008/06/30下载
020872015APLetter2005/10/19下载
020872015APLabel2005/10/19下载
020872011APLetter2003/06/08下载
020872011APLabel2003/05/29下载
020872010APReview2008/08/01下载
020872009APReview2008/08/01下载
020872008APReview2008/08/01下载
020872007APLetter2001/07/11下载
020872005APReview2008/08/04下载
020872004APLetter2001/10/29下载
020872004APReview2004/05/26下载
020872003APLabel2003/05/29下载
020872003APLetter2003/06/08下载
020872002APReview2004/05/26下载
020872002APLetter2001/10/29下载
020872001APLetter2001/10/29下载
020872001APReview2004/05/26下载
020872000APReview2004/05/26下载
020872000APLetter2000/02/25下载
020872000APLabel2000/02/25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
020872038AP2016/05/10Labeling Revision
020872037AP2016/03/23Manufacturing Change or Addition
020872036AP2015/09/18Manufacturing Change or Addition
020872035AP2015/09/24Manufacturing Change or Addition
020872033AP2014/12/02Manufacturing Change or Addition
020872032AP2014/09/12Labeling Revision
020872031AP2014/04/16Manufacturing Change or Addition
020872030AP2013/04/16Manufacturing Change or Addition
020872029AP2012/08/23Labeling Revision
020872025AP2012/02/23Labeling Revision
020872023AP2011/01/24OTC Labeling
020872018AP2008/06/25Labeling Revision
020872015AP2005/10/13New Dosage Regimen
020872011AP2003/05/12Efficacy Supplement with Clinical Data to Support
020872010AP2002/10/10Manufacturing Change or Addition
020872009AP2002/12/10Manufacturing Change or Addition
020872008AP2002/02/20Control Supplement
020872007AP2001/07/11Labeling Revision
020872005AP2001/01/05Manufacturing Change or Addition
020872004AP2001/05/30Control Supplement
020872003AP2003/05/12Efficacy Supplement with Clinical Data to Support
020872002AP2000/03/21Package Change
020872001AP2000/04/14Manufacturing Change or Addition
020872000AP2000/02/25Approval