药品名称HIBICLENS
申请号017768产品号001
活性成分CHLORHEXIDINE GLUCONATE市场状态非处方药
剂型或给药途径SOLUTION;TOPICAL规格4%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MOLNLYCKE HEALTH CARE
化学类型New active ingredient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
017768042APLabel2015/12/15下载
017768041APLetter2014/07/01下载
017768041APLabel2014/07/31下载
017768039APLetter2012/05/29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
017768042AP2015/12/09Manufacturing Change or Addition
017768041AP2014/06/30Labeling Revision
017768039AP2012/05/24Labeling Revision
017768033AP2002/07/02Manufacturing Change or Addition
017768032AP2001/12/12Manufacturing Change or Addition
017768031AP2000/02/23Package Change
017768030AP1999/10/20Package Change
017768029AP1998/09/30Control Supplement
017768028AP1994/03/30Package Change
017768027AP1989/07/14Formulation Revision
017768026AP1989/07/18Control Supplement
017768025AP1989/08/25Labeling Revision
017768024AP1988/05/11Manufacturing Change or Addition
017768023AP1988/03/03Labeling Revision
017768022AP1987/04/06Package Change
017768019AP1985/05/09Control Supplement
017768017AP1984/06/18Manufacturing Change or Addition
017768015AP1981/07/21Control Supplement
017768014AP1981/03/10Control Supplement
017768013AP1981/01/16Package Change
017768012AP1980/12/29Control Supplement
017768011AP1987/05/20Labeling Revision
017768010AP1980/07/30Formulation Revision
017768008AP1979/07/25Package Change
017768007AP1979/12/18Formulation Revision
017768006AP1979/12/18Manufacturing Change or Addition
017768005AP1981/07/06Labeling Revision
017768004AP1978/05/12Control Supplement
017768003AP1978/01/06Manufacturing Change or Addition
017768002AP1982/03/01General Efficacy (MarkIV)
017768001AP1977/05/09Control Supplement
017768000AP1976/09/17Approval