药品名称ZYRTEC HIVES RELIEF
申请号019835产品号006
活性成分CETIRIZINE HYDROCHLORIDE市场状态非处方药
剂型或给药途径TABLET;ORAL规格10MG
治疗等效代码参比药物
批准日期2007/11/16申请机构JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION
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
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
019835032APLetter2012/09/11下载
019835032APLabel2012/12/12下载
019835030APLetter2012/03/15下载
019835029APLetter2012/01/30下载
019835028APLetter2010/03/04下载
019835025APLetter2008/11/28下载
019835022APLetter2007/11/26下载
019835022APReview2008/05/21下载
019835020APLetter2006/04/07下载
019835016APReview2009/01/12下载
019835016APLetter2004/03/24下载
019835016APLabel2004/04/05下载
019835015APLetter2002/10/21下载
019835015APLabel2002/10/21下载
019835015APReview2009/01/12下载
019835005APLetter1998/05/15下载
019835005APReview1998/05/15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
019835036AP2016/04/04Manufacturing Change or Addition
019835035AP2015/01/20Manufacturing Change or Addition
019835034AP2014/09/26Manufacturing Change or Addition
019835032AP2012/09/10Labeling Revision
019835030AP2012/03/13Labeling Revision
019835029AP2012/01/26Labeling Revision
019835028AP2010/02/26Labeling Revision
019835026AP2010/02/26Labeling Revision
019835025AP2008/11/25Manufacturing Change or Addition
019835022AP2007/11/16OTC Labeling
019835020AP2006/04/04Formulation Revision
019835016AP2004/03/17Labeling Revision
019835015AP2002/10/21Patient Population Altered
019835013AP2000/09/19Control Supplement
019835011AP2000/02/01Manufacturing Change or Addition
019835010AP2000/02/25Labeling Revision
019835009AP2000/02/04Package Change
019835008AP1999/07/09Manufacturing Change or Addition
019835007AP1999/01/27Manufacturing Change or Addition
019835006AP1998/05/22Control Supplement
019835005AP1998/05/15New or Modified Indication
019835004AP1996/11/01Labeling Revision
019835003AP1996/11/14Control Supplement
019835002AP1996/09/23Labeling Revision
019835001AP1996/05/23Control Supplement
019835000AP1995/12/08Approval