药品名称 | PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER | 申请号 | 018406 | 产品号 | 002 | 活性成分 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 市场状态 | 停止上市 | 剂型或给药途径 | SOLUTION;IRRIGATION | 规格 | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1982/07/08 | 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 | 018406 | 051 | AP | 2000/02/23 | Labeling Revision | 018406 | 050 | AP | 1997/08/21 | Package Change | 018406 | 049 | AP | 1997/06/11 | Manufacturing Change or Addition | 018406 | 048 | AP | 1997/11/19 | Labeling Revision | 018406 | 047 | AP | 1997/03/28 | Control Supplement | 018406 | 046 | AP | 1996/10/22 | Package Change | 018406 | 045 | AP | 1996/08/29 | Control Supplement | 018406 | 044 | AP | 1996/08/27 | Control Supplement | 018406 | 042 | AP | 1995/08/14 | Control Supplement | 018406 | 039 | AP | 1991/08/30 | Package Change | 018406 | 038 | AP | 1992/01/28 | Package Change | 018406 | 037 | AP | 1991/09/10 | Control Supplement | 018406 | 035 | AP | 1990/01/11 | Manufacturing Change or Addition | 018406 | 034 | AP | 1990/02/22 | Manufacturing Change or Addition | 018406 | 033 | AP | 1988/10/17 | Control Supplement | 018406 | 030 | AP | 1987/07/30 | Control Supplement | 018406 | 029 | AP | 1986/11/26 | Control Supplement | 018406 | 028 | AP | 1986/08/08 | Control Supplement | 018406 | 027 | AP | 1986/02/21 | Control Supplement | 018406 | 026 | AP | 1986/10/31 | Labeling Revision | 018406 | 025 | AP | 1986/10/31 | Control Supplement | 018406 | 024 | AP | 1986/01/31 | Control Supplement | 018406 | 023 | AP | 1986/01/31 | Control Supplement | 018406 | 022 | AP | 1985/05/14 | Control Supplement | 018406 | 021 | AP | 1984/11/09 | Resubmission - Chemistry (MarkIV) | 018406 | 020 | AP | 1984/10/22 | Control Supplement | 018406 | 019 | AP | 1985/09/26 | Package Change | 018406 | 017 | AP | 1985/10/29 | Package Change | 018406 | 016 | AP | 1989/09/13 | Control Supplement | 018406 | 015 | AP | 1984/10/17 | Control Supplement | 018406 | 014 | AP | 1984/03/21 | Control Supplement | 018406 | 013 | AP | 1984/03/01 | Manufacturing Change or Addition | 018406 | 012 | AP | 1984/09/22 | Labeling Revision | 018406 | 011 | AP | 1984/09/22 | Package Change | 018406 | 010 | AP | 1982/07/26 | Control Supplement | 018406 | 009 | AP | 1984/03/01 | Control Supplement | 018406 | 008 | AP | 1982/06/18 | Control Supplement | 018406 | 007 | AP | 1982/02/01 | Control Supplement | 018406 | 006 | AP | 1982/01/08 | Control Supplement | 018406 | 005 | AP | 1982/06/09 | Control Supplement | 018406 | 004 | AP | 1981/04/29 | Control Supplement | 018406 | 003 | AP | 1981/09/16 | Control Supplement | 018406 | 002 | AP | 1982/07/08 | Practioner Draft Labeling | 018406 | 001 | AP | 1981/01/19 | Control Supplement | 018406 | 000 | AP | 1980/08/25 | Approval |
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