药品名称GALLIUM CITRATE GA 67
申请号018058产品号001
活性成分GALLIUM CITRATE GA-67市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格2mCi/ML
治疗等效代码BS参比药物
批准日期Approved Prior to Jan 1, 1982申请机构MALLINCKRODT NUCLEAR MEDICINE LLC
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)
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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
018058013AP2014/03/19Manufacturing Change or Addition
018058010AP1985/11/22Manufacturing Change or Addition
018058008AP1982/09/14Labeling Revision
018058007AP1982/09/27Labeling Revision
018058005AP1984/03/08Practioner Draft Labeling
018058004AP1982/05/07Control Supplement
018058003AP1981/12/11Manufacturing Change or Addition
018058002AP1980/07/04Manufacturing Change or Addition
018058001AP1980/07/04Control Supplement
018058000AP1979/02/01Approval