药品名称TRANDATE
申请号018716产品号004
活性成分LABETALOL HYDROCHLORIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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否
批准日期1984/08/01申请机构COUNTY LINE PHARMACEUTICALS LLC
化学类型New formulation or new manufacturer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
无
历史专利信息
无
与本品相关的市场独占权保护信息
独占权代码失效日期
无
历史市场独占权保护信息
无
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
018716026APLabel2010/11/22下载
018716026APLetter2010/11/30下载
018716023APLetter2003/05/29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
018716028AP2016/04/28Manufacturing Change or Addition
018716027AP2014/10/27Manufacturing Change or Addition
018716026AP2010/11/22Labeling Revision
018716023AP2003/04/23Manufacturing Change or Addition
018716022AP1998/08/13Labeling Revision
018716021AP1997/04/21Manufacturing Change or Addition
018716020AP1993/05/27Labeling Revision
018716019AP1991/06/05Labeling Revision
018716018AP1993/05/27Labeling Revision
018716017AP1991/02/01Labeling Revision
018716016AP1990/06/07Labeling Revision
018716015AP1990/11/07Labeling Revision
018716014AP1989/12/22Manufacturing Change or Addition
018716013AP1989/04/07Package Change
018716012AP1989/06/16Labeling Revision
018716011AP1989/06/16Labeling Revision
018716010AP1987/08/27Manufacturing Change or Addition
018716009AP1987/09/22Labeling Revision
018716008AP1986/11/13Labeling Revision
018716006AP1985/05/24Labeling Revision
018716005AP1985/05/24Labeling Revision
018716004AP1985/08/08Package Change
018716002AP1985/04/16Package Change
018716001AP1985/03/26Formulation Revision
018716000AP1984/08/01Approval