药品名称 | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 申请号 | 017607 | 产品号 | 001 | 活性成分 | DEXTROSE; SODIUM CHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 5GM/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 | 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 | 017607 | 153 | AP | 2014/09/08 | Manufacturing Change or Addition | 017607 | 119 | AP | 2002/07/18 | Labeling | 017607 | 118 | AP | 1999/03/31 | Labeling | 017607 | 117 | AP | 1998/12/01 | Chemistry | 017607 | 116 | AP | 1997/06/11 | Chemistry | 017607 | 115 | AP | 1997/08/20 | Labeling | 017607 | 114 | AP | 1997/03/28 | Chemistry | 017607 | 113 | AP | 1996/08/06 | Chemistry | 017607 | 112 | AP | 1996/03/04 | Chemistry | 017607 | 111 | AP | 1995/08/18 | Chemistry | 017607 | 110 | AP | 1996/08/29 | Chemistry | 017607 | 109 | AP | 1996/08/27 | Chemistry | 017607 | 107 | AP | 1995/08/14 | Chemistry | 017607 | 104 | AP | 1991/08/30 | Chemistry | 017607 | 104 | AP | 2014/09/17 | Manufacturing Change or Addition | 017607 | 103 | AP | 1992/01/28 | Chemistry | 017607 | 102 | AP | 1991/09/10 | Chemistry | 017607 | 100 | AP | 1990/01/11 | Chemistry | 017607 | 099 | AP | 1990/02/22 | Chemistry | 017607 | 096 | AP | 1987/07/30 | Chemistry | 017607 | 095 | AP | 1986/11/26 | Chemistry | 017607 | 094 | AP | 1986/08/08 | Chemistry | 017607 | 091 | AP | 1985/06/10 | Chemistry | 017607 | 090 | AP | 1985/09/30 | Chemistry | 017607 | 089 | AP | 1986/01/31 | Chemistry | 017607 | 086 | AP | 1985/08/27 | Chemistry | 017607 | 085 | AP | 1985/10/26 | Labeling | 017607 | 084 | AP | 1985/05/03 | Chemistry | 017607 | 083 | AP | 1985/10/26 | Chemistry | 017607 | 080 | AP | 1984/10/22 | Chemistry | 017607 | 079 | AP | 1985/09/26 | Chemistry | 017607 | 077 | AP | 1985/11/29 | Labeling | 017607 | 076 | AP | 1985/11/29 | Chemistry | 017607 | 075 | AP | 1985/10/29 | Chemistry | 017607 | 074 | AP | 1984/11/28 | Chemistry | 017607 | 073 | AP | 1988/08/31 | Chemistry | 017607 | 072 | AP | 1984/04/09 | Chemistry | 017607 | 071 | AP | 1984/06/14 | Chemistry | 017607 | 070 | AP | 1984/10/17 | Chemistry | 017607 | 069 | AP | 1984/03/21 | Chemistry | 017607 | 068 | AP | 1983/08/31 | Chemistry | 017607 | 067 | AP | 1983/12/08 | Chemistry | 017607 | 066 | AP | 1984/02/17 | Chemistry | 017607 | 065 | AP | 1983/06/06 | Chemistry | 017607 | 064 | AP | 1984/10/10 | Labeling | 017607 | 063 | AP | 1984/10/10 | Chemistry | 017607 | 062 | AP | 1982/07/26 | Chemistry | 017607 | 061 | AP | 1984/03/01 | Chemistry | 017607 | 060 | AP | 1983/02/15 | Chemistry | 017607 | 059 | AP | 1982/07/08 | Chemistry | 017607 | 058 | AP | 1982/02/01 | Chemistry | 017607 | 057 | AP | 1982/02/05 | Chemistry | 017607 | 056 | AP | 1982/01/08 | Chemistry | 017607 | 055 | AP | 1982/06/09 | Chemistry | 017607 | 054 | AP | 1981/10/07 | Chemistry | 017607 | 053 | AP | 1981/10/21 | Labeling | 017607 | 052 | AP | 1981/10/21 | Chemistry | 017607 | 051 | AP | 1981/03/02 | Labeling | 017607 | 050 | AP | 1982/08/31 | Labeling | 017607 | 049 | AP | 1981/03/02 | Labeling | 017607 | 048 | AP | 1981/03/02 | Chemistry | 017607 | 047 | AP | 1981/01/07 | Chemistry | 017607 | 046 | AP | 1980/09/15 | Chemistry | 017607 | 045 | AP | 1980/06/10 | Chemistry | 017607 | 044 | AP | 1980/02/12 | Chemistry | 017607 | 043 | AP | 1980/04/08 | Labeling | 017607 | 042 | AP | 1979/10/10 | Chemistry | 017607 | 041 | AP | 1979/11/29 | Chemistry | 017607 | 040 | AP | 1980/01/22 | Chemistry | 017607 | 039 | AP | 1979/11/27 | Chemistry | 017607 | 038 | AP | 1979/12/03 | Chemistry | 017607 | 037 | AP | 1979/12/03 | Chemistry | 017607 | 036 | AP | 1979/07/17 | Labeling | 017607 | 035 | AP | 1979/01/05 | Chemistry | 017607 | 034 | AP | 1979/02/01 | Other | 017607 | 033 | AP | 1978/11/07 | Labeling | 017607 | 032 | AP | 1978/11/08 | Chemistry | 017607 | 031 | AP | 1978/11/22 | Chemistry | 017607 | 030 | AP | 1978/10/11 | Chemistry | 017607 | 029 | AP | 1978/11/22 | Chemistry | 017607 | 028 | AP | 1979/02/06 | Chemistry | 017607 | 027 | AP | 1978/08/02 | Chemistry | 017607 | 026 | AP | 1978/08/15 | Chemistry | 017607 | 025 | AP | 1978/05/08 | Chemistry | 017607 | 023 | AP | 1978/06/26 | Chemistry | 017607 | 021 | AP | 1978/02/08 | Labeling | 017607 | 020 | AP | 1978/03/30 | Chemistry | 017607 | 019 | AP | 1978/06/14 | Chemistry | 017607 | 018 | AP | 1978/10/10 | Labeling | 017607 | 017 | AP | 1978/10/10 | Chemistry | 017607 | 016 | AP | 1978/02/13 | Chemistry | 017607 | 015 | AP | 1977/09/28 | Labeling | 017607 | 014 | AP | 1978/04/11 | Chemistry | 017607 | 011 | AP | 1978/01/23 | Chemistry | 017607 | 010 | AP | 1977/05/20 | Chemistry | 017607 | 009 | AP | 1977/05/03 | Chemistry | 017607 | 008 | AP | 1976/11/29 | Labeling | 017607 | 007 | AP | 1978/06/14 | Chemistry | 017607 | 006 | AP | 1977/04/29 | Chemistry | 017607 | 005 | AP | 1976/11/08 | Chemistry | 017607 | 004 | AP | 1975/10/17 | Labeling | 017607 | 003 | AP | 1975/11/20 | Chemistry | 017607 | 002 | AP | 1975/11/03 | Chemistry | 017607 | 001 | AP | 1975/10/15 | Chemistry | 017607 | 000 | AP | 1975/08/13 | Approval |
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