药品名称AVENTYL
申请号014685产品号001
活性成分NORTRIPTYLINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径SOLUTION;ORAL规格EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构RANBAXY PHARMACEUTICALS INC
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
014685028APLetter2007/07/31下载
014685028APLabel2007/07/31下载
014685026APLetter2005/01/13下载
014685026APLabel2005/01/13下载
014685000APOther 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
014685028AP2007/07/30Labeling Revision
014685026AP2005/01/12Labeling Revision
014685024AP2000/08/23Labeling Revision
014685023AP1998/05/29Manufacturing Change or Addition
014685022AP1998/04/24Control Supplement
014685021AP2000/08/23Labeling Revision
014685020AP1996/07/08Labeling Revision
014685019AP1996/07/08Labeling Revision
014685018AP1993/05/10Labeling Revision
014685017AP1993/05/10Labeling Revision
014685016AP1993/05/10Labeling Revision
014685015AP1990/06/20Labeling Revision
014685014AP1990/06/20Labeling Revision
014685013AP1989/02/16Control Supplement
014685012AP1987/01/09Labeling Revision
014685011AP1990/06/20Labeling Revision
014685010AP1985/10/25Labeling Revision
014685009AP1984/10/05Labeling Revision
014685008AP1984/05/24Control Supplement
014685007AP1984/02/27Labeling Revision
014685000AP1964/11/06Approval