药品名称R-GENE 10
申请号016931产品号001
活性成分ARGININE HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格10GM/100ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PHARMACIA AND UPJOHN CO
化学类型New formulation or new manufacturer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
016931031APLabel2010/01/24下载
016931031APLetter2010/01/26下载
016931028APLabel2003/08/15下载
016931028APLetter2003/08/15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
016931031AP2010/01/17Labeling Revision
016931028AP2003/08/13Labeling Revision
016931027AP2000/04/11Manufacturing Change or Addition
016931026AP1995/03/15Labeling Revision
016931025AP1993/03/17Control Supplement
016931024AP1991/10/09Control Supplement
016931023AP1990/02/28Labeling Revision
016931022AP1989/10/24Manufacturing Change or Addition
016931021AP1986/03/05Labeling Revision
016931020AP1985/07/29Labeling Revision
016931019AP1984/05/09Manufacturing Change or Addition
016931018AP1985/02/19Labeling Revision
016931017AP1982/01/11Control Supplement
016931014AP1980/06/30Labeling Revision
016931006AP1975/10/01Control Supplement
016931005AP1975/08/25Control Supplement
016931000AP1973/02/28Approval