药品名称PHENERGAN VC W/ CODEINE
申请号008306产品号005
活性成分CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径SYRUP;ORAL规格10MG/5ML;5MG/5ML;6.25MG/5ML
治疗等效代码参比药物
批准日期1984/04/02申请机构ANI PHARMACEUTICALS INC
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
008306031APLetter2013/05/13下载
008306031APLabel2013/05/14下载
008306030APLetter2008/11/28下载
008306030APLabel2009/01/02下载
008306029APReview2007/07/06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
008306031AP2013/05/09Labeling Revision
008306030AP2008/11/26Labeling Revision
008306029AP2001/02/23Labeling Revision
008306027AP2000/06/23Control Supplement
008306025AP1998/05/06Manufacturing Change or Addition
008306024AP1998/02/10Control Supplement
008306022AP1992/03/30Manufacturing Change or Addition
008306021AP1989/12/12Manufacturing Change or Addition
008306020AP1989/12/12Manufacturing Change or Addition
008306019AP1989/01/11Labeling Revision
008306018AP1988/06/30Control Supplement
008306016AP1985/11/04Labeling Revision
008306015AP1985/07/29Control Supplement
008306014AP1987/04/13Control Supplement
008306013AP1986/05/29Control Supplement
008306012AP1984/04/12Practioner Draft Labeling
008306011AP1984/04/02General Efficacy (MarkIV)
008306010AP1984/04/02Formulation Revision
008306000AP1952/01/21Approval