药品名称 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 申请号 | 018008 | 产品号 | 004 | 活性成分 | DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 5GM/100ML;150MG/100ML;450MG/100ML | 治疗等效代码 | AP | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | BAXTER HEALTHCARE CORP
| 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 | 018008 | 070 | AP | Label | 2013/09/11 | 下载![](pdf.jpg) | 018008 | 070 | AP | Letter | 2013/09/12 | 下载![](pdf.jpg) | 018008 | 066 | AP | Label | 2007/04/25 | 下载![](pdf.jpg) | 018008 | 066 | AP | Letter | 2007/05/01 | 下载![](pdf.jpg) | 018008 | 065 | AP | Label | 2005/08/31 | 下载![](pdf.jpg) | 018008 | 065 | AP | Letter | 2005/08/31 | 下载![](pdf.jpg) | 018008 | 063 | AP | Letter | 2004/06/07 | 下载![](pdf.jpg) | 018008 | 059 | AP | Letter | 2003/05/29 | 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 | 018008 | 071 | AP | 2014/09/26 | Manufacturing Change or Addition | 018008 | 070 | AP | 2013/09/10 | Labeling Revision | 018008 | 066 | AP | 2007/04/20 | Labeling Revision | 018008 | 065 | AP | 2005/08/26 | Package Change | 018008 | 063 | AP | 2004/06/02 | Labeling Revision | 018008 | 060 | AP | 2001/08/14 | Manufacturing Change or Addition | 018008 | 059 | AP | 2003/04/14 | Labeling Revision | 018008 | 058 | AP | 1999/11/24 | Manufacturing Change or Addition | 018008 | 057 | AP | 1997/04/29 | Package Change | 018008 | 056 | AP | 1994/02/18 | Control Supplement | 018008 | 055 | AP | 1994/09/30 | Control Supplement | 018008 | 054 | AP | 1993/04/22 | Labeling Revision | 018008 | 053 | AP | 1991/12/11 | Control Supplement | 018008 | 051 | AP | 1991/04/29 | Control Supplement | 018008 | 050 | AP | 1991/03/26 | Control Supplement | 018008 | 049 | AP | 1991/02/15 | Control Supplement | 018008 | 048 | AP | 1989/07/26 | Control Supplement | 018008 | 047 | AP | 1987/07/25 | Package Change | 018008 | 046 | AP | 1987/05/28 | Control Supplement | 018008 | 044 | AP | 1986/02/27 | Package Change | 018008 | 043 | AP | 1985/04/15 | Control Supplement | 018008 | 042 | AP | 1985/07/03 | Labeling Revision | 018008 | 041 | AP | 1985/06/13 | Control Supplement | 018008 | 040 | AP | 1984/10/23 | Control Supplement | 018008 | 039 | AP | 1984/02/28 | Control Supplement | 018008 | 037 | AP | 1985/08/28 | Control Supplement | 018008 | 036 | AP | 1985/08/28 | Control Supplement | 018008 | 035 | AP | 1984/03/16 | Control Supplement | 018008 | 034 | AP | 1985/01/24 | Control Supplement | 018008 | 032 | AP | 1982/05/25 | Labeling Revision | 018008 | 031 | AP | 1982/04/28 | Labeling Revision | 018008 | 029 | AP | 1983/07/11 | Practioner Draft Labeling | 018008 | 028 | AP | 1981/11/20 | Control Supplement | 018008 | 026 | AP | 1982/06/03 | Control Supplement | 018008 | 025 | AP | 1981/11/09 | Control Supplement | 018008 | 024 | AP | 1982/04/16 | Control Supplement | 018008 | 023 | AP | 1981/08/26 | Labeling Revision | 018008 | 022 | AP | 1981/12/21 | Control Supplement | 018008 | 020 | AP | 1981/06/29 | Control Supplement | 018008 | 019 | AP | 1981/05/29 | Control Supplement | 018008 | 018 | AP | 1981/01/21 | Control Supplement | 018008 | 017 | AP | 1980/07/31 | Control Supplement | 018008 | 014 | AP | 1980/08/06 | Control Supplement | 018008 | 013 | AP | 1981/04/16 | Control Supplement | 018008 | 012 | AP | 1980/02/22 | Labeling Revision | 018008 | 010 | AP | 1980/06/18 | Control Supplement | 018008 | 008 | AP | 1980/05/28 | Control Supplement | 018008 | 007 | AP | 1980/05/30 | Control Supplement | 018008 | 006 | AP | 1980/08/07 | Control Supplement | 018008 | 005 | AP | 1979/08/02 | Control Supplement | 018008 | 003 | AP | 1980/06/28 | Control Supplement | 018008 | 002 | AP | 1979/06/14 | Control Supplement | 018008 | 001 | AP | 1980/02/25 | Control Supplement | 018008 | 000 | AP | 1979/02/02 | Approval |
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