药品名称DESYREL
申请号018207产品号003
活性成分TRAZODONE HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格150MG
治疗等效代码参比药物
批准日期1985/03/25申请机构PRAGMA PHARMACEUTICALS LLC
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
81338932029/03/13YYPDF格式
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
018207031APLetter2014/07/21下载
018207030APLetter2005/01/13下载
018207030APLabel2005/01/13下载
018207029APLetter2004/03/19下载
018207000APOther Important Information from FDA2007/05/09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
018207031AP2014/07/17Labeling Revision
018207030AP2005/01/12Labeling Revision
018207029AP2004/03/17Labeling Revision
018207027AP1996/06/21Manufacturing Change or Addition
018207026AP1996/06/25Control Supplement
018207025AP1996/06/25Control Supplement
018207024AP1996/02/07Control Supplement
018207023AP2000/04/14Labeling Revision
018207020AP1990/03/05Manufacturing Change or Addition
018207019AP1988/10/26Manufacturing Change or Addition
018207018AP1988/04/14Control Supplement
018207017AP1988/01/22Control Supplement
018207015AP1986/09/03Manufacturing Change or Addition
018207014AP1988/11/07New Dosage Regimen
018207013AP2000/04/14Labeling Revision
018207012AP1986/09/02New Dosage Regimen
018207011AP1986/02/26Manufacturing Change or Addition
018207010AP1985/09/19Labeling Revision
018207009AP1985/07/10Control Supplement
018207007AP1985/09/27Labeling Revision
018207006AP1983/10/24Labeling Revision
018207005AP1983/11/29Control Supplement
018207004AP1985/03/25Formulation Revision
018207003AP1986/09/03Control Supplement
018207002AP1983/04/04Manufacturing Change or Addition
018207001AP1982/02/01Labeling Revision
018207000AP1981/12/24Approval