药品名称NORGESIC
申请号013416产品号003
活性成分ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格385MG;30MG;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1982/10/27申请机构MEDICIS PHARMACEUTICAL CORP
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
013416021APLetter2002/11/25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
013416029AP1999/03/26Control Supplement
013416028AP1997/09/12Control Supplement
013416027AP1995/06/13Control Supplement
013416026AP1993/12/16Manufacturing Change or Addition
013416024AP1988/03/30Manufacturing Change or Addition
013416023AP1993/11/05Control Supplement
013416022AP1987/04/28Package Change
013416021AP2002/11/25Practioner Draft Labeling
013416020AP1986/01/31Labeling Revision
013416012AP1977/07/27Package Change
013416011AP1977/07/27Package Change
013416000AP1964/03/04Approval