药品名称RUBRATOPE-57 KIT
申请号016089产品号001
活性成分COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR市场状态停止上市
剂型或给药途径N/A;N/A规格N/A;N/A;N/A;N/A
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRACCO DIAGNOSTICS INC
化学类型New 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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与本品相关的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
016089029AP2001/07/20Manufacturing Change or Addition
016089028AP1994/03/21Control Supplement
016089027AP1985/09/30Manufacturing Change or Addition
016089026AP1984/05/29Practioner Draft Labeling
016089025AP1984/05/29Practioner Draft Labeling
016089023AP1980/01/22Labeling Revision
016089022AP1981/03/03Manufacturing Change or Addition
016089021AP1981/03/03Manufacturing Change or Addition
016089020AP1979/11/08Labeling Revision
016089019AP1979/08/06Labeling Revision
016089018AP1978/05/12Control Supplement
016089017AP1978/05/12Labeling Revision
016089016AP1977/08/04Labeling Revision
016089000AP1970/12/21Approval