药品名称TENEX
申请号019032产品号001
活性成分GUANFACINE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 1MG BASE
治疗等效代码AB参比药物
批准日期1986/10/27申请机构PROMIUS PHARMA 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
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
019032021APLetter2013/07/05下载
019032021APLabel2013/07/05下载
019032017APReview2002/05/30下载
019032017APLetter2002/03/12下载
019032016APLetter2002/03/12下载
019032016APReview2002/05/30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
019032021AP2013/07/03Labeling Revision
019032017AP2002/03/12Labeling Revision
019032016AP2002/03/12Labeling Revision
019032015AP1998/01/13Manufacturing Change or Addition
019032014AP1991/09/17Control Supplement
019032013AP1991/03/01Manufacturing Change or Addition
019032012AP1989/11/29Control Supplement
019032011AP1990/02/01Labeling Revision
019032010AP1993/05/11New or Modified Indication
019032009AP1988/11/07Labeling Revision
019032008AP1988/06/09Package Change
019032007AP1988/11/07Control Supplement
019032006AP1987/12/28Package Change
019032005AP1987/11/20Control Supplement
019032004AP1987/04/29Manufacturing Change or Addition
019032002AP1987/02/17Package Change
019032001AP1987/02/17Control Supplement
019032000AP1986/10/27Approval