药品名称PULMOLITE
申请号017776产品号001
活性成分TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格N/A
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JUBILANT DRAXIMAGE 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
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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
017776019AP2002/07/30Manufacturing Change or Addition
017776018AP2001/05/24Manufacturing Change or Addition
017776016AP2000/06/15Manufacturing Change or Addition
017776015AP2000/02/07Manufacturing Change or Addition
017776014AP1999/07/13Control Supplement
017776013AP1998/03/24Manufacturing Change or Addition
017776012AP1997/10/01Control Supplement
017776011AP1995/01/25Control Supplement
017776010AP1989/05/02Manufacturing Change or Addition
017776009AP1989/05/19Labeling Revision
017776008AP1985/05/03Control Supplement
017776007AP1992/07/31Control Supplement
017776006AP1983/05/31Control Supplement
017776005AP1985/10/22Practioner Draft Labeling
017776004AP1980/07/24Formulation Revision
017776000AP1976/11/16Approval