药品名称 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 申请号 | 016366 | 产品号 | 001 | 活性成分 | SODIUM CHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 900MG/100ML | 治疗等效代码 | AP | 参比药物 | 是 | 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 | 016366 | 215 | AP | 2016/04/27 | Manufacturing Change or Addition | 016366 | 212 | AP | 2014/09/08 | Manufacturing Change or Addition | 016366 | 201 | AP | 2014/09/17 | Manufacturing Change or Addition | 016366 | 161 | AP | 2002/11/01 | Package Change | 016366 | 160 | AP | 2000/05/03 | Labeling | 016366 | 159 | AP | 2000/05/03 | Packager Addition | 016366 | 157 | AP | 1998/12/01 | Chemistry | 016366 | 156 | AP | 1997/08/21 | Chemistry | 016366 | 155 | AP | 1997/08/20 | Chemistry | 016366 | 154 | AP | 1997/06/11 | Chemistry | 016366 | 153 | AP | 1999/06/25 | Labeling | 016366 | 152 | AP | 1997/03/28 | Chemistry | 016366 | 151 | AP | 1996/08/06 | Chemistry | 016366 | 150 | AP | 1996/03/04 | Chemistry | 016366 | 149 | AP | 1996/03/29 | Chemistry | 016366 | 148 | AP | 1996/03/29 | Chemistry | 016366 | 146 | AP | 1995/08/14 | Chemistry | 016366 | 145 | AP | 1994/05/24 | Labeling | 016366 | 142 | AP | 1991/08/30 | Chemistry | 016366 | 141 | AP | 1992/01/28 | Chemistry | 016366 | 140 | AP | 1991/09/10 | Chemistry | 016366 | 138 | AP | 1990/01/11 | Chemistry | 016366 | 137 | AP | 1990/02/22 | Chemistry | 016366 | 136 | AP | 1989/06/14 | Chemistry | 016366 | 135 | AP | 1988/10/17 | Chemistry | 016366 | 134 | AP | 1988/06/07 | Chemistry | 016366 | 131 | AP | 1987/07/30 | Chemistry | 016366 | 130 | AP | 1986/11/26 | Chemistry | 016366 | 129 | AP | 1986/06/24 | Chemistry | 016366 | 128 | AP | 1986/01/18 | Chemistry | 016366 | 127 | AP | 1986/02/22 | Chemistry | 016366 | 124 | AP | 1985/06/21 | Chemistry | 016366 | 123 | AP | 1985/06/10 | Chemistry | 016366 | 122 | AP | 1985/11/07 | Labeling | 016366 | 120 | AP | 1986/01/31 | Chemistry | 016366 | 119 | AP | 1985/08/27 | Chemistry | 016366 | 114 | AP | 1985/10/26 | Labeling | 016366 | 111 | AP | 1985/05/03 | Chemistry | 016366 | 110 | AP | 1985/10/26 | Chemistry | 016366 | 109 | AP | 1985/01/18 | Labeling | 016366 | 108 | AP | 1985/01/18 | Chemistry | 016366 | 105 | AP | 1984/10/22 | Chemistry | 016366 | 104 | AP | 1985/09/26 | Chemistry | 016366 | 102 | AP | 1985/04/23 | Labeling | 016366 | 101 | AP | 1985/04/23 | Chemistry | 016366 | 100 | AP | 1985/11/29 | Labeling | 016366 | 099 | AP | 1985/11/29 | Chemistry | 016366 | 098 | AP | 1985/10/29 | Chemistry | 016366 | 097 | AP | 1986/02/25 | Chemistry | 016366 | 096 | AP | 1986/08/06 | Chemistry | 016366 | 095 | AP | 1985/01/08 | Labeling | 016366 | 094 | AP | 1985/01/08 | Chemistry | 016366 | 093 | AP | 1984/04/09 | Chemistry | 016366 | 092 | AP | 1984/06/14 | Chemistry | 016366 | 091 | AP | 1984/09/25 | Chemistry | 016366 | 090 | AP | 1984/10/17 | Chemistry | 016366 | 089 | AP | 1984/03/21 | Chemistry | 016366 | 088 | AP | 1983/08/31 | Chemistry | 016366 | 087 | AP | 1983/01/17 | Chemistry | 016366 | 086 | AP | 1983/12/08 | Chemistry | 016366 | 085 | AP | 1983/09/19 | Chemistry | 016366 | 084 | AP | 1983/06/06 | Chemistry | 016366 | 083 | AP | 1983/01/25 | Chemistry | 016366 | 082 | AP | 1984/10/10 | Labeling | 016366 | 081 | AP | 1984/10/10 | Chemistry | 016366 | 080 | AP | 1982/07/26 | Chemistry | 016366 | 079 | AP | 1984/03/01 | Chemistry | 016366 | 078 | AP | 1983/02/15 | Chemistry | 016366 | 077 | AP | 1982/05/26 | Chemistry | 016366 | 076 | AP | 1982/02/22 | Labeling | 016366 | 075 | AP | 1982/02/01 | Chemistry | 016366 | 074 | AP | 1982/01/08 | Chemistry | 016366 | 073 | AP | 1982/06/09 | Chemistry | 016366 | 072 | AP | 1981/08/25 | Chemistry | 016366 | 071 | AP | 1981/10/21 | Labeling | 016366 | 070 | AP | 1981/10/21 | Chemistry | 016366 | 069 | AP | 1981/09/16 | Chemistry | 016366 | 068 | AP | 1981/07/31 | Labeling | 016366 | 067 | AP | 1981/07/31 | Chemistry | 016366 | 066 | AP | 1981/03/02 | Labeling | 016366 | 065 | AP | 1982/08/31 | Labeling | 016366 | 064 | AP | 1981/03/02 | Labeling | 016366 | 063 | AP | 1981/03/02 | Chemistry | 016366 | 062 | AP | 1981/01/07 | Chemistry | 016366 | 061 | AP | 1980/09/15 | Chemistry | 016366 | 059 | AP | 1981/07/16 | Chemistry | 016366 | 058 | AP | 1980/06/10 | Chemistry | 016366 | 057 | AP | 1980/05/28 | Chemistry | 016366 | 056 | AP | 1980/02/12 | Chemistry | 016366 | 055 | AP | 1980/04/08 | Labeling | 016366 | 054 | AP | 1979/10/10 | Chemistry | 016366 | 053 | AP | 1979/11/29 | Chemistry | 016366 | 052 | AP | 1980/01/21 | Chemistry | 016366 | 051 | AP | 1980/04/16 | Labeling | 016366 | 050 | AP | 1980/04/16 | Chemistry | 016366 | 049 | AP | 1979/11/27 | Chemistry | 016366 | 048 | AP | 1979/12/03 | Chemistry | 016366 | 047 | AP | 1979/12/03 | Chemistry | 016366 | 046 | AP | 1979/07/17 | Labeling | 016366 | 045 | AP | 1979/01/05 | Chemistry | 016366 | 044 | AP | 1979/02/01 | Chemistry | 016366 | 043 | AP | 1979/02/16 | Chemistry | 016366 | 042 | AP | 1978/10/25 | Labeling | 016366 | 041 | AP | 1978/10/25 | Chemistry | 016366 | 040 | AP | 1979/03/27 | Labeling | 016366 | 039 | AP | 1979/03/27 | Chemistry | 016366 | 038 | AP | 1978/09/08 | Chemistry | 016366 | 037 | AP | 1978/10/27 | Labeling | 016366 | 036 | AP | 1978/10/27 | Chemistry | 016366 | 035 | AP | 1978/11/20 | Chemistry | 016366 | 034 | AP | 1979/03/27 | Labeling | 016366 | 033 | AP | 1979/03/27 | Chemistry | 016366 | 032 | AP | 1979/02/06 | Chemistry | 016366 | 031 | AP | 1978/11/03 | Chemistry | 016366 | 030 | AP | 1978/08/15 | Chemistry | 016366 | 029 | AP | 1978/09/08 | Chemistry | 016366 | 027 | AP | 1978/06/26 | Chemistry | 016366 | 026 | AP | 1978/04/06 | Labeling | 016366 | 025 | AP | 1978/02/08 | Labeling | 016366 | 024 | AP | 1978/06/02 | Labeling | 016366 | 023 | AP | 1978/06/02 | Chemistry | 016366 | 022 | AP | 1978/04/05 | Chemistry | 016366 | 021 | AP | 1978/05/31 | Chemistry | 016366 | 018 | AP | 1978/02/13 | Chemistry | 016366 | 017 | AP | 1977/09/28 | Labeling | 016366 | 016 | AP | 1978/03/15 | Chemistry | 016366 | 015 | AP | 1978/01/23 | Chemistry | 016366 | 014 | AP | 1977/08/15 | Chemistry | 016366 | 013 | AP | 1977/08/15 | Labeling | 016366 | 012 | AP | 1978/06/08 | Chemistry | 016366 | 011 | AP | 1977/04/29 | Chemistry | 016366 | 009 | AP | 1976/11/08 | Chemistry | 016366 | 008 | AP | 1975/11/20 | Chemistry | 016366 | 007 | AP | 1975/09/03 | Chemistry | 016366 | 006 | AP | 1975/10/29 | Chemistry | 016366 | 005 | AP | 1975/05/19 | Chemistry | 016366 | 004 | AP | 1975/03/07 | Other | 016366 | 002 | AP | 1975/05/19 | Labeling | 016366 | 001 | AP | 1976/03/02 | Labeling | 016366 | 000 | AP | 1972/02/24 | Approval |
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