药品名称8-HOUR BAYER
申请号016030产品号001
活性成分ASPIRIN市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格650MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BAYER HEALTHCARE LLC
化学类型New dosage form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
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
016030043AP1995/10/25Control Supplement
016030042AP1994/04/21Control Supplement
016030041AP1991/10/23Manufacturing Change or Addition
016030040AP1990/09/17Manufacturing Change or Addition
016030039AP1987/09/23Manufacturing Change or Addition
016030038AP1987/09/23Manufacturing Change or Addition
016030037AP1986/06/20Labeling Revision
016030036AP1986/06/20Labeling Revision
016030035AP1986/06/20Labeling Revision
016030034AP1986/06/20Labeling Revision
016030033AP1985/02/04Package Change
016030032AP1984/03/16Package Change
016030031AP1983/10/25Package Change
016030030AP1983/09/09Package Change
016030029AP1983/04/14Labeling Revision
016030028AP1983/01/11Manufacturing Change or Addition
016030027AP1983/06/08Package Change
016030026AP1983/04/07Package Change
016030025AP1982/01/06Package Change
016030024AP1980/10/17Manufacturing Change or Addition
016030023AP1980/02/28Control Supplement
016030022AP1979/07/24Manufacturing Change or Addition
016030021AP1979/07/24Manufacturing Change or Addition
016030020AP1979/03/02Package Change
016030017AP1975/12/12Control Supplement
016030000AP1965/06/25Approval