药品名称MINTEZOL
申请号016096产品号001
活性成分THIABENDAZOLE市场状态停止上市
剂型或给药途径TABLET, CHEWABLE;ORAL规格500MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MERCK SHARP AND DOHME CORP
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
016096033APLetter2003/06/22下载
016096033APLabel2003/06/22下载
016096030APLetter2001/06/19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
016096033AP2003/06/11Labeling Revision
016096032AP2002/10/24Manufacturing Change or Addition
016096031AP2002/03/27Control Supplement
016096030AP2001/06/29Labeling Revision
016096029AP1996/08/07Package Change
016096028AP1995/12/26Manufacturing Change or Addition
016096027AP1994/06/16Control Supplement
016096026AP1992/07/01Manufacturing Change or Addition
016096025AP1991/12/30Manufacturing Change or Addition
016096024AP1996/06/03Labeling Revision
016096023AP1990/11/19Control Supplement
016096022AP1990/04/04Control Supplement
016096021AP1985/10/18Labeling Revision
016096020AP1985/01/23Control Supplement
016096018AP1984/08/09Package Change
016096017AP1987/04/06Labeling Revision
016096016AP1985/04/01Labeling Revision
016096015AP1983/11/07Practioner Draft Labeling
016096014AP1983/11/07Labeling Revision
016096013AP1981/06/04Control Supplement
016096012AP1978/04/17Labeling Revision
016096011AP1977/05/03Labeling Revision
016096009AP1976/06/24Formulation Revision
016096008AP1976/04/15Labeling Revision
016096007AP1975/02/25Control Supplement
016096000AP1967/04/07Approval