药品名称 | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 申请号 | 018362 | 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;149MG/100ML;450MG/100ML | 治疗等效代码 | AP | 参比药物 | 否 | 批准日期 | 1988/03/28 | 申请机构 | HOSPIRA 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 | 无 |
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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 | 018362 | 095 | AP | 2014/09/08 | Manufacturing Change or Addition | 018362 | 071 | AP | 2002/07/18 | Labeling | 018362 | 070 | AP | 1999/05/27 | Labeling | 018362 | 069 | AP | 1999/01/21 | Chemistry | 018362 | 068 | AP | 1998/12/01 | Chemistry | 018362 | 066 | AP | 1997/06/11 | Chemistry | 018362 | 065 | AP | 1997/08/20 | Labeling | 018362 | 064 | AP | 1996/08/06 | Chemistry | 018362 | 063 | AP | 1996/03/04 | Chemistry | 018362 | 062 | AP | 1995/08/18 | Chemistry | 018362 | 061 | AP | 1996/08/29 | Chemistry | 018362 | 060 | AP | 1996/08/27 | Chemistry | 018362 | 059 | AP | 1995/08/14 | Chemistry | 018362 | 056 | AP | 1991/08/30 | Chemistry | 018362 | 055 | AP | 1992/01/28 | Chemistry | 018362 | 054 | AP | 1991/09/10 | Chemistry | 018362 | 052 | AP | 1990/01/11 | Chemistry | 018362 | 051 | AP | 1990/02/22 | Chemistry | 018362 | 049 | AP | 1988/03/28 | Labeling | 018362 | 048 | AP | 1988/03/28 | Chemistry | 018362 | 046 | AP | 1986/11/26 | Chemistry | 018362 | 045 | AP | 1986/08/08 | Chemistry | 018362 | 044 | AP | 1986/01/31 | Chemistry | 018362 | 043 | AP | 1985/06/10 | Chemistry | 018362 | 042 | AP | 1986/01/31 | Chemistry | 018362 | 040 | AP | 1985/10/26 | Labeling | 018362 | 039 | AP | 1985/05/03 | Chemistry | 018362 | 038 | AP | 1985/10/26 | Chemistry | 018362 | 037 | AP | 1984/11/09 | Resubmission - Chemistry (MarkIV) | 018362 | 034 | AP | 1984/10/22 | Chemistry | 018362 | 033 | AP | 1985/09/26 | Chemistry | 018362 | 031 | AP | 1985/11/29 | Labeling | 018362 | 030 | AP | 1985/11/29 | Chemistry | 018362 | 029 | AP | 1985/10/29 | Chemistry | 018362 | 028 | AP | 1984/11/28 | Chemistry | 018362 | 027 | AP | 1988/08/31 | Chemistry | 018362 | 026 | AP | 1984/04/09 | Chemistry | 018362 | 025 | AP | 1984/10/17 | Chemistry | 018362 | 024 | AP | 1984/03/21 | Chemistry | 018362 | 023 | AP | 1983/07/05 | Labeling | 018362 | 022 | AP | 1983/07/05 | Chemistry | 018362 | 021 | AP | 1983/12/08 | Chemistry | 018362 | 020 | AP | 1984/02/17 | Chemistry | 018362 | 019 | AP | 1984/10/10 | Labeling | 018362 | 018 | AP | 1984/10/10 | Chemistry | 018362 | 017 | AP | 1982/07/26 | Chemistry | 018362 | 016 | AP | 1984/03/01 | Chemistry | 018362 | 015 | AP | 1983/02/15 | Chemistry | 018362 | 014 | AP | 1982/06/18 | Chemistry | 018362 | 013 | AP | 1982/07/08 | Chemistry | 018362 | 012 | AP | 1982/02/01 | Chemistry | 018362 | 011 | AP | 1982/01/08 | Chemistry | 018362 | 010 | AP | 1982/06/09 | Chemistry | 018362 | 009 | AP | 1981/10/07 | Chemistry | 018362 | 008 | AP | 1981/07/27 | Labeling | 018362 | 006 | AP | 1981/06/12 | Labeling | 018362 | 005 | AP | 1981/04/08 | Labeling | 018362 | 004 | AP | 1981/04/08 | Chemistry | 018362 | 003 | AP | 1981/01/07 | Chemistry | 018362 | 002 | AP | 1980/09/15 | Chemistry | 018362 | 001 | AP | 1980/08/13 | Chemistry | 018362 | 000 | AP | 1980/05/29 | Approval |
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