药品名称ANCOBON
申请号017001产品号002
活性成分FLUCYTOSINE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格500MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构VALEANT PHARMACEUTICALS INTERNATIONAL
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
017001028APLetter2009/05/07下载
017001027APLabel2006/08/11下载
017001027APLetter2006/08/11下载
017001020APLabel2003/05/06下载
017001020APLetter2003/05/29下载
017001019APLabel2003/05/06下载
017001019APLetter2003/05/29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
017001031AP2016/02/05Manufacturing Change or Addition
017001030AP2014/01/08Manufacturing Change or Addition
017001028AP2009/05/04Labeling Revision
017001027AP2006/08/10Labeling Revision
017001024AP2000/02/03Manufacturing Change or Addition
017001023AP1999/09/29Control Supplement
017001022AP1997/08/27Package Change
017001021AP1997/07/31Manufacturing Change or Addition
017001020AP2003/04/30Labeling Revision
017001019AP2003/04/30Labeling Revision
017001017AP1984/08/08Package Change
017001016AP1983/12/21Control Supplement
017001015AP1982/12/06Control Supplement
017001014AP1982/01/27Control Supplement
017001013AP1987/06/01Practioner Draft Labeling
017001012AP1981/04/23Control Supplement
017001011AP1979/11/26Control Supplement
017001010AP1978/08/24Formulation Revision
017001009AP1978/01/03Control Supplement
017001008AP1977/08/11Formulation Revision
017001007AP1977/05/13Control Supplement
017001000AP1971/11/26Approval