药品名称GASTROGRAFIN
申请号011245产品号003
活性成分DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM市场状态处方药
剂型或给药途径SOLUTION;ORAL, RECTAL规格66%;10%
治疗等效代码AA参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRACCO DIAGNOSTICS INC
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
011245032APLetter2005/08/31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
011245032AP2005/08/29Control Supplement
011245030AP2000/12/15Manufacturing Change or Addition
011245029AP1994/08/05Labeling Revision
011245028AP1994/05/19Manufacturing Change or Addition
011245027AP1991/03/05Package Change
011245026AP1985/01/28Manufacturing Change or Addition
011245023AP1983/09/14Practioner Draft Labeling
011245022AP1983/08/03Package Change
011245021AP1983/02/02Labeling Revision
011245020AP1983/09/14General Efficacy (MarkIV)
011245019AP1979/09/13Labeling Revision
011245018AP1978/12/28Formulation Revision
011245017AP1978/02/27Control Supplement
011245016AP1978/09/16Control Supplement
011245013AP1975/09/25Control Supplement
011245012AP1976/09/08Labeling Revision
011245000AP1958/01/17Approval