药品名称FIORINAL W/CODEINE
申请号019429产品号003
活性成分ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格325MG;50MG;40MG;30MG
治疗等效代码AB参比药物
批准日期1990/10/26申请机构ALLERGAN SALES LLC
化学类型New combination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
019429035APLetter2013/05/13下载
019429035APLabel2013/05/14下载
019429023APLabel2008/04/28下载
019429023APLetter2008/04/28下载
019429023APOther2008/04/28下载
019429006APLetter2002/08/26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
019429038AP2015/11/06Manufacturing Change or Addition
019429037AP2014/11/16Manufacturing Change or Addition
019429035AP2013/05/09Labeling Revision
019429023AP2008/04/08Labeling Revision
019429019AP2002/04/26Control Supplement
019429018AP2001/06/28Manufacturing Change or Addition
019429017AP2001/05/30Control Supplement
019429016AP2001/10/04Labeling Revision
019429015AP1999/11/10Manufacturing Change or Addition
019429013AP1999/04/22Package Change
019429011AP1996/07/12Control Supplement
019429010AP1995/11/20Manufacturing Change or Addition
019429009AP1996/03/21Control Supplement
019429007AP1995/10/20Control Supplement
019429006AP2002/08/26Labeling Revision
019429005AP1994/04/05Manufacturing Change or Addition
019429004AP1993/04/06Control Supplement
019429003AP1993/04/06Package Change
019429002AP1993/04/06Package Change
019429001AP1991/04/29Labeling Revision
019429000AP1990/10/26Approval