药品名称 | DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 申请号 | 016689 | 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;200MG/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 | 016689 | 105 | AP | Label | 2013/09/11 | 下载 | 016689 | 105 | AP | Letter | 2013/09/12 | 下载 |
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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 | 016689 | 106 | AP | 2014/09/26 | Manufacturing Change or Addition | 016689 | 105 | AP | 2013/09/10 | Labeling Revision | 016689 | 098 | AP | 2004/06/02 | Labeling Revision | 016689 | 096 | AP | 2001/08/14 | Manufacturing Change or Addition | 016689 | 095 | AP | 1999/11/24 | Manufacturing Change or Addition | 016689 | 094 | AP | 2000/11/29 | Labeling Revision | 016689 | 093 | AP | 1997/04/29 | Package Change | 016689 | 092 | AP | 1996/10/11 | Package Change | 016689 | 091 | AP | 1994/02/18 | Control Supplement | 016689 | 090 | AP | 1994/09/30 | Control Supplement | 016689 | 087 | AP | 1991/04/29 | Control Supplement | 016689 | 086 | AP | 1991/03/26 | Control Supplement | 016689 | 085 | AP | 1991/02/15 | Control Supplement | 016689 | 084 | AP | 1989/07/26 | Control Supplement | 016689 | 083 | AP | 1989/01/12 | Control Supplement | 016689 | 082 | AP | 1987/07/25 | Package Change | 016689 | 081 | AP | 1987/05/28 | Control Supplement | 016689 | 078 | AP | 1986/02/27 | Package Change | 016689 | 077 | AP | 1985/04/15 | Control Supplement | 016689 | 076 | AP | 1985/07/03 | Labeling Revision | 016689 | 074 | AP | 1985/06/13 | Control Supplement | 016689 | 073 | AP | 1984/09/22 | Control Supplement | 016689 | 072 | AP | 1984/02/28 | Control Supplement | 016689 | 070 | AP | 1985/08/28 | Control Supplement | 016689 | 069 | AP | 1985/08/28 | Control Supplement | 016689 | 068 | AP | 1984/03/16 | Control Supplement | 016689 | 067 | AP | 1985/01/24 | Control Supplement | 016689 | 065 | AP | 1982/02/16 | Control Supplement | 016689 | 064 | AP | 1983/07/11 | Practioner Draft Labeling | 016689 | 063 | AP | 1981/11/20 | Control Supplement | 016689 | 061 | AP | 1982/06/03 | Control Supplement | 016689 | 060 | AP | 1981/11/09 | Control Supplement | 016689 | 059 | AP | 1982/04/16 | Control Supplement | 016689 | 058 | AP | 1981/08/26 | Labeling Revision | 016689 | 057 | AP | 1981/12/21 | Control Supplement | 016689 | 056 | AP | 1981/05/20 | Control Supplement | 016689 | 054 | AP | 1981/06/29 | Control Supplement | 016689 | 053 | AP | 1981/01/21 | Control Supplement | 016689 | 052 | AP | 1980/07/31 | Control Supplement | 016689 | 051 | AP | 1980/08/06 | Control Supplement | 016689 | 050 | AP | 1981/04/16 | Control Supplement | 016689 | 048 | AP | 1980/06/18 | Control Supplement | 016689 | 047 | AP | 1980/05/30 | Control Supplement | 016689 | 046 | AP | 1980/02/22 | Control Supplement | 016689 | 045 | AP | 1980/08/07 | Control Supplement | 016689 | 043 | AP | 1980/06/28 | Control Supplement | 016689 | 042 | AP | 1979/08/02 | Control Supplement | 016689 | 040 | AP | 1978/10/12 | Control Supplement | 016689 | 039 | AP | 1978/10/20 | Control Supplement | 016689 | 038 | AP | 1978/08/07 | Control Supplement | 016689 | 037 | AP | 1978/08/02 | Control Supplement | 016689 | 036 | AP | 1978/11/03 | Control Supplement | 016689 | 035 | AP | 1978/04/25 | Labeling Revision | 016689 | 034 | AP | 1978/03/22 | Control Supplement | 016689 | 033 | AP | 1980/02/25 | Control Supplement | 016689 | 032 | AP | 1978/06/20 | Control Supplement | 016689 | 031 | AP | 1978/03/24 | Control Supplement | 016689 | 030 | AP | 1978/02/28 | Control Supplement | 016689 | 029 | AP | 1977/12/14 | Control Supplement | 016689 | 028 | AP | 1977/06/06 | Control Supplement | 016689 | 027 | AP | 1977/02/07 | Package Change | 016689 | 026 | AP | 1976/10/20 | Labeling Revision | 016689 | 025 | AP | 1976/07/13 | Final Printed Labeling - MarkIV | 016689 | 024 | AP | 1976/06/17 | Control Supplement | 016689 | 022 | AP | 1976/01/02 | Labeling Revision | 016689 | 021 | AP | 1976/07/01 | Control Supplement | 016689 | 020 | AP | 1976/01/05 | Control Supplement | 016689 | 019 | AP | 1976/11/26 | Labeling Revision | 016689 | 018 | AP | 1975/09/23 | Control Supplement | 016689 | 017 | AP | 1976/05/11 | Labeling Revision | 016689 | 016 | AP | 1975/09/17 | Control Supplement | 016689 | 015 | AP | 1975/09/25 | Control Supplement | 016689 | 013 | AP | 1975/07/10 | Control Supplement | 016689 | 000 | AP | 1970/12/08 | Approval |
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