药品名称CHRONULAC
申请号017884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剂型或给药途径SOLUTION;ORAL规格10GM/15ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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SANOFI AVENTIS US LLC
化学类型New formulation or new manufacturer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
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
017884022AP1993/02/02Control Supplement
017884021AP1992/04/13Manufacturing Change or Addition
017884019AP1990/02/22Manufacturing Change or Addition
017884018AP1988/12/09Package Change
017884017AP1989/05/16Manufacturing Change or Addition
017884016AP1988/05/27Control Supplement
017884015AP1988/12/07Package Change
017884014AP1987/03/09Manufacturing Change or Addition
017884013AP1984/02/28Control Supplement
017884011AP1983/01/21Control Supplement
017884010AP1981/10/22Labeling Revision
017884009AP1981/10/22Expiration Date Change
017884008AP1980/10/03Labeling Revision
017884007AP1980/07/07Package Change
017884006AP1979/12/28Labeling Revision
017884005AP1980/03/04Control Supplement
017884004AP1979/12/28Package Change
017884003AP1980/07/29Control Supplement
017884002AP1979/12/28Control Supplement
017884001AP1979/12/28Package Change
017884000AP1979/06/20Approval