药品名称DARANIDE
申请号011366产品号001
活性成分DICHLORPHENAMIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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TARO PHARMACEUTICALS USA 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
011366030APLabel2015/08/10下载
011366030APLetter2015/08/10下载
011366028APLetter2012/03/19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
011366030AP2015/08/07Efficacy Supplement with Clinical Data to Support
011366029AP2013/12/19Manufacturing Change or Addition
011366028AP2012/03/16Control Supplement
011366027AP1994/10/24Labeling Revision
011366026AP1995/06/13Control Supplement
011366025AP1989/06/02Manufacturing Change or Addition
011366024AP1991/02/12Control Supplement
011366023AP1985/09/06Labeling Revision
011366022AP1985/09/06Control Supplement
011366021AP1984/08/06Control Supplement
011366020AP1982/02/26Control Supplement
011366018AP1986/11/05Practioner Draft Labeling
011366017AP1979/12/18Labeling Revision
011366016AP1979/12/20Labeling Revision
011366015AP1978/07/28Control Supplement
011366000AP1958/07/22Approval