药品名称CLARITIN HIVES RELIEF
申请号020641产品号003
活性成分LORATADINE市场状态停止上市
剂型或给药途径SYRUP;ORAL规格1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期2003/11/19申请机构BAYER HEALTHCARE 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
历史专利信息
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
020641042APLetter2016/08/10下载
020641042APLabel2016/08/22下载
020641040APLetter2015/12/31下载
020641040APLabel2016/01/04下载
020641038APLetter2015/11/09下载
020641038APLabel2015/11/25下载
020641037APLetter2015/10/23下载
020641037APLabel2015/10/26下载
020641036APLabel2015/04/21下载
020641036APLetter2015/04/22下载
020641032APLetter2013/03/01下载
020641032APLabel2014/01/14下载
020641025APLetter2008/07/30下载
020641024APLetter2008/07/30下载
020641018APLetter2005/06/15下载
020641017APLetter2004/10/29下载
020641016APLetter2004/07/21下载
020641011APLetter2003/11/25下载
020641009APReview2004/12/07下载
020641009APLetter2002/11/27下载
020641007APLetter2000/12/04下载
020641007APLabel2000/12/04下载
020641007APReview2000/12/04下载
020641003APReview2007/03/02下载
020641001APReview2007/03/02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
020641042AP2016/08/09Labeling Revision
020641041AP2016/02/12Manufacturing Change or Addition
020641040AP2015/12/30Labeling Revision
020641039AP2015/12/10Manufacturing Change or Addition
020641038AP2015/11/05Labeling Revision
020641037AP2015/10/21Manufacturing Change or Addition
020641036AP2015/04/16Manufacturing Change or Addition
020641035AP2014/05/15Manufacturing Change or Addition
020641033AP2013/04/16Manufacturing Change or Addition
020641032AP2013/02/28Manufacturing Change or Addition
020641030AP2012/11/20Manufacturing Change or Addition
020641025AP2008/07/25Labeling Revision
020641024AP2008/07/25Package Change
020641018AP2005/06/14Formulation Revision
020641017AP2004/10/27Control Supplement
020641016AP2004/07/15Package Change
020641012AP2002/12/09Package Change
020641011AP2003/11/19OTC Labeling
020641010AP2002/07/23Expiration Date Change
020641009AP2002/11/27OTC Labeling
020641007AP2000/12/04Patient Population Altered
020641006AP1999/01/07Formulation Revision
020641003AP1998/10/29Manufacturing Change or Addition
020641002AP1998/03/30Labeling Revision
020641001AP1998/01/23Manufacturing Change or Addition
020641000AP1996/10/10Approval