药品名称THAM-E
申请号013025产品号001
活性成分POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格370MG/VIAL;1.75GM/VIAL;36GM/VIAL
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构HOSPIRA INC
化学类型审评分类Priority 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
013025040APLabel2006/07/20下载
013025040APLetter2006/07/21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
013025055AP2013/11/08Manufacturing Change or Addition
013025054AP2013/06/25Manufacturing Change or Addition
013025040AP2006/07/20Manufacturing Change or Addition
013025037AP2000/02/11Labeling Revision
013025036AP1998/02/12Manufacturing Change or Addition
013025035AP2000/07/26Labeling Revision
013025034AP1996/03/29Control Supplement
013025033AP1994/09/30Manufacturing Change or Addition
013025032AP1989/01/27Control Supplement
013025031AP1986/06/12Manufacturing Change or Addition
013025026AP1986/01/31Control Supplement
013025025AP1984/11/09Resubmission - Chemistry (MarkIV)
013025024AP1984/08/03Labeling Revision
013025023AP1983/07/05Control Supplement
013025022AP1982/06/18Control Supplement
013025021AP1981/12/17Labeling Revision
013025020AP1984/01/09Control Supplement
013025019AP1982/09/27Practioner Draft Labeling
013025018AP1982/09/27Practioner Draft Labeling
013025017AP1980/10/14Control Supplement
013025016AP1980/10/06Control Supplement
013025015AP1980/06/06Control Supplement
013025014AP1980/05/29Control Supplement
013025013AP1977/07/27Control Supplement
013025012AP1976/12/08Control Supplement
013025011AP1976/03/01Control Supplement
013025010AP1975/11/14Control Supplement
013025000AP1965/12/16Approval