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 | 否 | 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 |
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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 | 无 | 历史专利信息 | 无 |
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与本品相关的市场独占权保护信息 | 独占权代码 | 失效日期 | 无 | 历史市场独占权保护信息 | 无 |
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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 | 017766 | 030 | AP | Label | 2006/05/05 | 下载 | 017766 | 030 | AP | Letter | 2006/05/05 | 下载 | 017766 | 029 | AP | Letter | 2004/05/07 | 下载 | 017766 | 029 | AP | Label | 2004/05/07 | 下载 | 017766 | 028 | AP | Letter | 2002/06/12 | 下载 |
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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 | 017766 | 041 | AP | 2014/08/27 | Manufacturing Change or Addition | 017766 | 036 | AP | 2013/03/19 | Manufacturing Change or Addition | 017766 | 030 | AP | 2006/05/04 | Labeling Revision | 017766 | 029 | AP | 2004/05/05 | Control Supplement | 017766 | 028 | AP | 2002/06/12 | Labeling Revision | 017766 | 027 | AP | 1996/06/14 | Control Supplement | 017766 | 026 | AP | 1994/10/28 | Manufacturing Change or Addition | 017766 | 025 | AP | 1993/06/08 | Control Supplement | 017766 | 024 | AP | 1992/09/28 | Manufacturing Change or Addition | 017766 | 023 | AP | 1991/12/11 | Manufacturing Change or Addition | 017766 | 022 | AP | 1991/12/18 | Manufacturing Change or Addition | 017766 | 021 | AP | 1990/04/11 | Control Supplement | 017766 | 018 | AP | 1988/01/13 | Labeling Revision | 017766 | 017 | AP | 1987/07/09 | Labeling Revision | 017766 | 016 | AP | 1986/10/09 | Labeling Revision | 017766 | 015 | AP | 1985/09/10 | Labeling Revision | 017766 | 014 | AP | 1985/04/23 | Labeling Revision | 017766 | 013 | AP | 1985/06/14 | Package Change | 017766 | 012 | AP | 1988/04/11 | Labeling Revision | 017766 | 011 | AP | 1988/04/11 | Package Change | 017766 | 010 | AP | 1982/05/18 | Control Supplement | 017766 | 009 | AP | 1982/10/08 | Practioner Draft Labeling | 017766 | 008 | AP | 1982/06/17 | Control Supplement | 017766 | 007 | AP | 1981/05/04 | Control Supplement | 017766 | 006 | AP | 1980/12/10 | Control Supplement | 017766 | 005 | AP | 1979/08/31 | Labeling Revision | 017766 | 004 | AP | 1979/08/31 | Control Supplement | 017766 | 003 | AP | 1979/01/05 | Package Change | 017766 | 002 | AP | 1979/01/04 | Manufacturing Change or Addition | 017766 | 001 | AP | 1978/07/11 | Labeling Revision | 017766 | 000 | AP | 1978/02/24 | Approval |
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