药品名称FIORICET W/ CODEINE
申请号020232产品号001
活性成分ACETAMINOPHEN; 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1992/07/30申请机构ACTAVIS LABORATORIES UT INC
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
020232036APLetter2013/10/22下载
020232036APLabel2013/10/22下载
020232035APLetter2013/05/13下载
020232035APLabel2013/05/14下载
020232033APLetter2011/06/28下载
020232033APLabel2011/06/29下载
020232021APLabel2008/03/24下载
020232021APLetter2008/03/24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
020232039AP2015/07/31Manufacturing Change or Addition
020232039AP2015/08/11Manufacturing Change or Addition
020232038AP2015/06/16Manufacturing Change or Addition
020232037AP2014/06/05Manufacturing Change or Addition
020232036AP2013/10/18Labeling Revision
020232035AP2013/05/09Labeling Revision
020232033AP2011/06/22Labeling Revision
020232021AP2008/03/21Labeling Revision
020232016AP2002/04/26Control Supplement
020232015AP2002/01/03Control Supplement
020232014AP2001/05/22Manufacturing Change or Addition
020232013AP2001/05/30Control Supplement
020232012AP2001/10/04Labeling Revision
020232010AP1999/08/03Manufacturing Change or Addition
020232009AP1999/04/22Package Change
020232008AP1998/05/20Labeling Revision
020232005AP1995/11/08Manufacturing Change or Addition
020232004AP1996/01/18Labeling Revision
020232002AP1994/03/29Package Change
020232001AP1992/12/01Control Supplement
020232000AP1992/07/30Approval