药品名称TRECATOR
申请号013026产品号002
活性成分ETHIONAMIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格250MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WYETH PHARMACEUTICALS INC
化学类型New molecular entity (NME)审评分类Priority 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
013026029APLetter2016/08/23下载
013026029APLabel2016/08/23下载
013026024APLabel2006/06/20下载
013026024APLetter2006/06/20下载
013026023APLetter2004/11/15下载
013026023APLabel2004/11/15下载
013026022APLetter2004/11/15下载
013026022APLabel2004/11/15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
013026029AP2016/08/22Labeling Revision
013026028AP2014/04/29Manufacturing Change or Addition
013026024AP2006/06/14Labeling Revision
013026023AP2004/11/08Formulation Revision
013026022AP2004/11/08Manufacturing Change or Addition
013026021AP2001/10/03Control Supplement
013026020AP2001/07/31Expiration Date Change
013026019AP1998/11/12Formulation Revision
013026018AP1998/10/05Control Supplement
013026017AP1998/04/23Manufacturing Change or Addition
013026016AP1994/05/17Control Supplement
013026015AP1994/03/18Control Supplement
013026013AP1992/12/29Control Supplement
013026012AP1991/04/26Control Supplement
013026011AP1990/05/11Formulation Revision
013026010AP1989/06/21Control Supplement
013026008AP1988/05/31Manufacturing Change or Addition
013026007AP1987/06/04Package Change
013026006AP1987/03/03Control Supplement
013026005AP1984/10/26Formulation Revision
013026004AP1981/04/01Control Supplement
013026003AP1974/06/20Supplement
013026000AP1965/04/30Approval