药品名称SURMONTIL
申请号016792产品号001
活性成分TRIMIPRAMINE MALEATE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格EQ 25MG BASE
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ODYSSEY PHARMACEUTICALS 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
016792037APLetter2014/07/21下载
016792037APLabel2014/07/29下载
016792034APLabel2012/12/03下载
016792034APLetter2012/12/05下载
016792025APLabel2007/08/02下载
016792025APLetter2007/08/07下载
016792024APLetter2005/01/13下载
016792024APLabel2005/01/13下载
016792020APReview2002/05/02下载
016792019APReview2002/05/02下载
016792018APReview2002/05/02下载
016792015APReview2002/05/02下载
016792000APOther Important Information from FDA2007/05/09下载
016792000APMedication Guide2012/12/04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
016792037AP2014/07/17Labeling Revision
016792036AP2014/09/30Manufacturing Change or Addition
016792035AP2013/12/23Manufacturing Change or Addition
016792034AP2012/12/03Labeling Revision
016792025AP2007/08/01Labeling Revision
016792024AP2005/01/12Labeling Revision
016792020AP2000/05/01Labeling Revision
016792019AP2000/04/27Labeling Revision
016792018AP2000/04/27Labeling Revision
016792017AP1992/04/03Control Supplement
016792016AP1992/04/03Manufacturing Change or Addition
016792015AP2000/04/27Labeling Revision
016792014AP1991/12/16Control Supplement
016792012AP1988/04/20Manufacturing Change or Addition
016792011AP1988/06/17Package Change
016792010AP1987/07/24Manufacturing Change or Addition
016792009AP1987/02/02Package Change
016792006AP1982/11/12Package Change
016792005AP1982/10/05Package Change
016792004AP1981/08/24Control Supplement
016792003AP1982/09/15Formulation Revision
016792002AP1981/03/26Package Change
016792001AP1980/07/08Labeling Revision
016792000AP1979/06/12Approval