药品名称 | PHYSIOSOL IN PLASTIC CONTAINER | 申请号 | 017637 | 产品号 | 002 | 活性成分 | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 市场状态 | 处方药 | 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 | 017637 | 061 | AP | 2014/06/12 | Manufacturing Change or Addition | 017637 | 047 | AP | 1999/06/04 | Control Supplement | 017637 | 046 | AP | 2000/02/23 | Labeling Revision | 017637 | 045 | AP | 1998/02/04 | Package Change | 017637 | 044 | AP | 1998/05/12 | Labeling Revision | 017637 | 043 | AP | 1996/08/27 | Control Supplement | 017637 | 041 | AP | 1992/06/30 | Control Supplement | 017637 | 040 | AP | 1993/08/24 | Package Change | 017637 | 039 | AP | 1988/11/25 | Control Supplement | 017637 | 038 | AP | 1986/01/31 | Control Supplement | 017637 | 037 | AP | 1985/10/29 | Control Supplement | 017637 | 035 | AP | 1986/01/18 | Control Supplement | 017637 | 034 | AP | 1984/11/09 | Resubmission - Chemistry (MarkIV) | 017637 | 033 | AP | 1984/10/22 | Control Supplement | 017637 | 031 | AP | 1984/08/25 | Control Supplement | 017637 | 030 | AP | 1984/03/15 | Package Change | 017637 | 029 | AP | 1982/06/18 | Control Supplement | 017637 | 028 | AP | 1984/03/01 | Control Supplement | 017637 | 027 | AP | 1982/06/10 | Package Change | 017637 | 026 | AP | 1981/11/06 | Control Supplement | 017637 | 025 | AP | 1982/07/08 | Practioner Draft Labeling | 017637 | 024 | AP | 1980/10/01 | Labeling Revision | 017637 | 023 | AP | 1980/09/08 | Control Supplement | 017637 | 022 | AP | 1980/06/06 | Control Supplement | 017637 | 020 | AP | 1980/06/06 | Control Supplement | 017637 | 019 | AP | 1980/05/23 | Control Supplement | 017637 | 018 | AP | 1981/07/21 | Control Supplement | 017637 | 017 | AP | 1980/03/20 | Control Supplement | 017637 | 014 | AP | 1979/10/04 | Control Supplement | 017637 | 013 | AP | 1979/07/31 | Package Change | 017637 | 012 | AP | 1979/07/18 | Control Supplement | 017637 | 011 | AP | 1979/01/05 | Control Supplement | 017637 | 010 | AP | 1979/02/02 | Control Supplement | 017637 | 009 | AP | 1979/04/30 | Control Supplement | 017637 | 008 | AP | 1978/12/01 | Control Supplement | 017637 | 007 | AP | 1978/11/22 | Labeling Revision | 017637 | 006 | AP | 1978/11/22 | Control Supplement | 017637 | 005 | AP | 1978/09/08 | Labeling Revision | 017637 | 004 | AP | 1978/08/29 | Control Supplement | 017637 | 003 | AP | 1978/06/30 | Control Supplement | 017637 | 002 | AP | 1978/09/08 | Labeling Revision | 017637 | 000 | AP | 1978/02/08 | Approval |
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