药品名称PROMETHAZINE HYDROCHLORIDE PLAIN
申请号008381产品号004
活性成分PROMETHAZINE HYDROCHLORIDE市场状态停止上市
剂型或给药途径SYRUP;ORAL规格6.25MG/5ML
治疗等效代码参比药物
批准日期1984/04/18申请机构ANI PHARMACEUTICALS INC
化学类型New active ingredient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
008381030APLabel2008/11/12下载
008381030APLetter2008/11/13下载
008381028APLetter2008/04/09下载
008381028APLabel2008/04/16下载
008381027APLetter2003/07/06下载
008381026APLetter2003/07/06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
008381030AP2008/11/10Labeling Revision
008381028AP2008/04/02Manufacturing Change or Addition
008381027AP2003/06/27Labeling Revision
008381026AP2003/06/27Supplement
008381024AP1998/05/06Manufacturing Change or Addition
008381023AP1992/03/30Manufacturing Change or Addition
008381022AP1992/02/06Control Supplement
008381021AP1989/12/12Manufacturing Change or Addition
008381020AP1989/12/13Manufacturing Change or Addition
008381019AP1988/06/30Control Supplement
008381018AP1988/04/06Labeling Revision
008381014AP1987/03/02Labeling Revision
008381013AP1986/09/08Labeling Revision
008381012AP1985/11/04Labeling Revision
008381011AP1985/07/27Control Supplement
008381010AP1986/05/29Control Supplement
008381009AP1984/04/18New or Modified Indication
008381008AP1984/04/18Formulation Revision
008381007AP1984/04/18Practioner Draft Labeling
008381000AP1952/04/11Approval