药品名称TROPHAMINE 10%
申请号019018产品号003
活性成分AMINO ACIDS市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10% (10GM/100ML)
治疗等效代码参比药物
批准日期1988/09/07申请机构B BRAUN MEDICAL INC
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
019018018APLetter2004/03/28下载
019018018APLabel2004/04/05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
019018032AP2014/01/17Manufacturing Change or Addition
019018031AP2013/11/08Manufacturing Change or Addition
019018026AP2013/03/19Manufacturing Change or Addition
019018018AP2004/03/24Control Supplement
019018017AP2000/06/20Control Supplement
019018016AP2000/04/11Control Supplement
019018015AP1996/06/14Control Supplement
019018014AP1994/10/28Manufacturing Change or Addition
019018013AP1992/09/28Manufacturing Change or Addition
019018012AP1991/12/11Manufacturing Change or Addition
019018011AP1990/04/11Control Supplement
019018010AP1998/04/23Control Supplement
019018008AP1988/12/19Control Supplement
019018006AP1988/09/07Labeling Revision
019018005AP1988/09/07Formulation Revision
019018004AP1988/01/13Labeling Revision
019018003AP1987/07/09Labeling Revision
019018002AP1986/10/09Labeling Revision
019018001AP1985/02/21Labeling Revision
019018000AP1984/07/20Approval