药品名称NEPHRAMINE 5.4%
申请号017766产品号001
活性成分AMINO ACIDS市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格5.4% (5.4GM/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B BRAUN MEDICAL 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
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
017766030APLabel2006/05/05下载
017766030APLetter2006/05/05下载
017766029APLetter2004/05/07下载
017766029APLabel2004/05/07下载
017766028APLetter2002/06/12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
017766041AP2014/08/27Manufacturing Change or Addition
017766036AP2013/03/19Manufacturing Change or Addition
017766030AP2006/05/04Labeling Revision
017766029AP2004/05/05Control Supplement
017766028AP2002/06/12Labeling Revision
017766027AP1996/06/14Control Supplement
017766026AP1994/10/28Manufacturing Change or Addition
017766025AP1993/06/08Control Supplement
017766024AP1992/09/28Manufacturing Change or Addition
017766023AP1991/12/11Manufacturing Change or Addition
017766022AP1991/12/18Manufacturing Change or Addition
017766021AP1990/04/11Control Supplement
017766018AP1988/01/13Labeling Revision
017766017AP1987/07/09Labeling Revision
017766016AP1986/10/09Labeling Revision
017766015AP1985/09/10Labeling Revision
017766014AP1985/04/23Labeling Revision
017766013AP1985/06/14Package Change
017766012AP1988/04/11Labeling Revision
017766011AP1988/04/11Package Change
017766010AP1982/05/18Control Supplement
017766009AP1982/10/08Practioner Draft Labeling
017766008AP1982/06/17Control Supplement
017766007AP1981/05/04Control Supplement
017766006AP1980/12/10Control Supplement
017766005AP1979/08/31Labeling Revision
017766004AP1979/08/31Control Supplement
017766003AP1979/01/05Package Change
017766002AP1979/01/04Manufacturing Change or Addition
017766001AP1978/07/11Labeling Revision
017766000AP1978/02/24Approval