药品名称CEPHULAC
申请号017657产品号001
活性成分LACTULOSE市场状态停止上市
剂型或给药途径SOLUTION;ORAL, RECTAL规格10GM/15ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SANOFI AVENTIS US LLC
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
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
017657032AP1993/02/09Control Supplement
017657031AP1992/04/13Manufacturing Change or Addition
017657030AP1991/04/05Package Change
017657028AP1990/02/22Manufacturing Change or Addition
017657027AP1988/12/09Package Change
017657026AP1989/05/16Manufacturing Change or Addition
017657025AP1987/09/18Labeling Revision
017657024AP1988/05/27Control Supplement
017657023AP1988/12/07Package Change
017657022AP1987/03/09Manufacturing Change or Addition
017657021AP1984/05/31Control Supplement
017657019AP1983/01/14Control Supplement
017657018AP1981/10/22Labeling Revision
017657017AP1981/10/22Expiration Date Change
017657016AP1980/11/13Labeling Revision
017657015AP1980/10/03Labeling Revision
017657014AP1980/08/20Package Change
017657013AP1980/06/20Labeling Revision
017657012AP1980/03/04Control Supplement
017657011AP1979/12/27Control Supplement
017657009AP1980/07/29Control Supplement
017657008AP1978/11/21Labeling Revision
017657007AP1979/05/04Package Change
017657006AP1977/12/08Labeling Revision
017657005AP1977/12/08Package Change
017657004AP1977/11/03Expiration Date Change
017657003AP1977/05/12Labeling Revision
017657002AP1977/05/12Package Change
017657001AP1980/06/27General Efficacy (MarkIV)
017657000AP1976/03/25Approval