药品名称REMERON
申请号020415产品号002
活性成分MIRTAZAPINE市场状态处方药
剂型或给药途径TABLET;ORAL规格30MG
治疗等效代码AB参比药物
批准日期1996/06/14申请机构ORGANON USA 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
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
020415032APLetter2015/12/31下载
020415032APLabel2015/12/31下载
020415031APLetter2014/07/23下载
020415031APLabel2014/07/30下载
020415030APLabel2016/08/01下载
020415030APLetter2016/08/03下载
020415026APLetter2012/11/01下载
020415026APLabel2012/11/06下载
020415026APMedication Guide2012/11/06下载
020415024APLetter2010/05/21下载
020415024APLabel2010/05/28下载
020415023APLabel2010/05/28下载
020415023APLetter2010/05/21下载
020415022APLabel2011/12/27下载
020415022APLetter2011/12/29下载
020415019APLabel2007/07/31下载
020415019APLetter2007/08/02下载
020415018APLetter2005/01/13下载
020415018APLabel2005/01/13下载
020415016APLetter2004/06/07下载
020415015APLetter2002/10/02下载
020415009APLetter2002/04/16下载
020415003APReview2004/09/08下载
020415000APOther Important Information from FDA2005/08/01下载
020415000APMedication Guide2009/11/20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
020415032AP2015/12/30Labeling Revision
020415031AP2014/07/18Labeling Revision
020415030AP2016/07/08Labeling Revision
020415028AP2014/09/30Manufacturing Change or Addition
020415027AP2012/12/11Manufacturing Change or Addition
020415026AP2012/10/30Labeling Revision
020415024AP2010/05/14Labeling Revision
020415023AP2010/05/14Labeling Revision
020415022AP2011/12/27Labeling Revision
020415019AP2007/07/30Labeling Revision
020415018AP2005/01/12Labeling Revision
020415016AP2004/06/01Labeling Revision
020415015AP2002/09/30Labeling Revision
020415014AP2001/11/20Manufacturing Change or Addition
020415010AP2001/01/26Manufacturing Change or Addition
020415009AP2002/04/09Efficacy Supplement with Clinical Data to Support
020415008AP2000/07/19Control Supplement
020415007AP2000/02/28Labeling Revision
020415006AP2000/08/30Labeling Revision
020415005AP1999/05/11Manufacturing Change or Addition
020415004AP1998/04/09Manufacturing Change or Addition
020415003AP1997/03/17Control Supplement
020415002AP1996/11/07Control Supplement
020415001AP1996/11/04Control Supplement
020415000AP1996/06/14Approval