药品名称DIMETANE
申请号010799产品号010
活性成分BROMPHENIRAMINE MALEATE市场状态停止上市
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格8MG
治疗等效代码参比药物
批准日期1983/06/10申请机构WYETH CONSUMER HEALTHCARE
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
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
010799073AP1998/04/14Manufacturing Change or Addition
010799071AP1996/04/30Labeling Revision
010799070AP1996/02/06Control Supplement
010799069AP1992/06/03Control Supplement
010799068AP1989/01/24Control Supplement
010799067AP1989/01/24Labeling Revision
010799066AP1988/03/24Control Supplement
010799065AP1988/03/17Control Supplement
010799064AP1986/06/17Labeling Revision
010799063AP1986/06/10Control Supplement
010799062AP1985/05/28Control Supplement
010799060AP1985/06/24Control Supplement
010799059AP1984/08/17Control Supplement
010799058AP1984/12/19Control Supplement
010799057AP1983/04/15General Efficacy (MarkIV)
010799056AP1983/04/15Control Supplement
010799053AP1984/08/17Control Supplement
010799052AP1986/07/10Control Supplement
010799051AP1986/09/04Control Supplement
010799035AP1983/06/10Labeling Revision
010799034AP1983/06/10Control Supplement
010799000AP1957/08/23Approval