药品名称 | AMINOSYN 3.5% M | 申请号 | 017789 | 产品号 | 003 | 活性成分 | AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/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 | HOSPIRA INC
| 化学类型 | New dosage form | 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 | 017789 | 052 | AP | Letter | 2004/05/27 | 下载![](pdf.jpg) | 017789 | 051 | AP | Letter | 2003/06/22 | 下载![](pdf.jpg) |
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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 | 017789 | 052 | AP | 2002/10/25 | Manufacturing Change or Addition | 017789 | 051 | AP | 2003/06/12 | Labeling Revision | 017789 | 050 | AP | 1999/01/22 | Control Supplement | 017789 | 049 | AP | 1997/05/05 | Control Supplement | 017789 | 048 | AP | 1996/08/27 | Control Supplement | 017789 | 047 | AP | 1994/07/11 | Manufacturing Change or Addition | 017789 | 046 | AP | 1993/12/30 | Control Supplement | 017789 | 045 | AP | 1992/08/18 | Manufacturing Change or Addition | 017789 | 044 | AP | 1992/02/10 | Manufacturing Change or Addition | 017789 | 043 | AP | 1987/07/13 | Labeling Revision | 017789 | 040 | AP | 1986/01/31 | Control Supplement | 017789 | 039 | AP | 1985/10/26 | Control Supplement | 017789 | 038 | AP | 1984/10/04 | Labeling Revision | 017789 | 037 | AP | 1983/07/05 | Control Supplement | 017789 | 036 | AP | 1983/07/05 | Control Supplement | 017789 | 035 | AP | 1983/10/13 | Labeling Revision | 017789 | 034 | AP | 1983/10/13 | Control Supplement | 017789 | 033 | AP | 1982/06/29 | Manufacturing Change or Addition | 017789 | 032 | AP | 1984/11/19 | Practioner Draft Labeling | 017789 | 031 | AP | 1981/12/07 | Labeling Revision | 017789 | 030 | AP | 1981/09/15 | Labeling Revision | 017789 | 029 | AP | 1981/09/15 | Formulation Revision | 017789 | 028 | AP | 1981/02/04 | Control Supplement | 017789 | 027 | AP | 1981/11/02 | Control Supplement | 017789 | 026 | AP | 1981/05/29 | Labeling Revision | 017789 | 025 | AP | 1981/05/29 | Control Supplement | 017789 | 024 | AP | 1980/06/27 | Control Supplement | 017789 | 023 | AP | 1980/07/01 | Labeling Revision | 017789 | 022 | AP | 1979/11/26 | Control Supplement | 017789 | 021 | AP | 1979/10/29 | Control Supplement | 017789 | 020 | AP | 1980/01/23 | Control Supplement | 017789 | 019 | AP | 1980/01/23 | Control Supplement | 017789 | 018 | AP | 1978/12/27 | Control Supplement | 017789 | 017 | AP | 1979/02/12 | Control Supplement | 017789 | 016 | AP | 1979/02/13 | Labeling Revision | 017789 | 015 | AP | 1979/02/13 | Control Supplement | 017789 | 014 | AP | 1979/05/02 | Control Supplement | 017789 | 013 | AP | 1979/03/09 | Labeling Revision | 017789 | 012 | AP | 1979/03/09 | Control Supplement | 017789 | 011 | AP | 1979/01/04 | Labeling Revision | 017789 | 010 | AP | 1978/12/19 | Control Supplement | 017789 | 009 | AP | 1978/05/26 | Control Supplement | 017789 | 006 | AP | 1977/07/25 | Control Supplement | 017789 | 004 | AP | 1977/04/07 | Control Supplement | 017789 | 003 | AP | 1977/02/11 | Control Supplement | 017789 | 002 | AP | 1978/01/23 | Control Supplement | 017789 | 001 | AP | 1976/11/23 | Control Supplement | 017789 | 000 | AP | 1976/05/14 | Approval |
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