药品名称GLEOSTINE
申请号017588产品号001
活性成分LOMUSTINE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格10MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构CORDEN PHARMA LATINA SPA
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
017588043APLetter2016/02/01下载
017588043APLabel2016/02/02下载
017588042APLetter2016/01/07下载
017588042APLabel2016/01/07下载
017588040APLetter2014/05/22下载
017588040APLabel2014/05/28下载
017588039APLabel2013/08/21下载
017588037APLetter2011/05/16下载
017588037APLabel2011/05/16下载
017588036APLetter2012/11/23下载
017588036APLabel2012/11/28下载
017588034APLetter2009/05/06下载
017588034APLabel2009/05/11下载
017588033APLetter2003/03/10下载
017588031APLetter2002/12/20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
017588043AP2016/01/29Labeling Revision
017588042AP2016/01/06Labeling Revision
017588041AP2015/01/05Manufacturing Change or Addition
017588040AP2014/05/20Labeling Revision
017588039AP2013/08/15Labeling Revision
017588038AP2013/08/14Manufacturing Change or Addition
017588037AP2011/05/12Labeling Revision
017588036AP2012/11/21Labeling Revision
017588034AP2009/04/30Labeling Revision
017588033AP2003/02/27Labeling Revision
017588032AP1999/06/01Manufacturing Change or Addition
017588031AP2002/12/20Labeling Revision
017588030AP1993/03/02Control Supplement
017588029AP1990/08/01Control Supplement
017588028AP1988/11/14Manufacturing Change or Addition
017588027AP1991/03/14Control Supplement
017588026AP1988/07/05Control Supplement
017588025AP1987/08/26Manufacturing Change or Addition
017588024AP1986/09/12Manufacturing Change or Addition
017588023AP1986/09/12Manufacturing Change or Addition
017588022AP1986/09/22Labeling Revision
017588020AP1986/09/22Labeling Revision
017588019AP1985/06/18Manufacturing Change or Addition
017588017AP1985/03/06Control Supplement
017588015AP1983/06/28Labeling Revision
017588012AP1983/07/22Labeling Revision
017588011AP1986/10/14Practioner Draft Labeling
017588010AP1982/02/16Labeling Revision
017588009AP1980/11/12Package Change
017588008AP1980/11/12Labeling Revision
017588007AP1980/08/07Expiration Date Change
017588005AP1980/09/19Formulation Revision
017588004AP1978/11/14Labeling Revision
017588002AP1977/04/22Control Supplement
017588000AP1976/08/04Approval