药品名称 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 申请号 | 016733 | 产品号 | 001 | 活性成分 | SODIUM CHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | SOLUTION;IRRIGATION | 规格 | 900MG/100ML | 治疗等效代码 | AT | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | B BRAUN MEDICAL 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 | 016733 | 049 | AP | Letter | 2006/10/23 | 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 | 016733 | 055 | AP | 2014/05/23 | Manufacturing Change or Addition | 016733 | 054 | AP | 2015/03/30 | Manufacturing Change or Addition | 016733 | 053 | AP | 2013/04/19 | Manufacturing Change or Addition | 016733 | 052 | AP | 2013/05/08 | Manufacturing Change or Addition | 016733 | 049 | AP | 2006/10/20 | Labeling Revision | 016733 | 047 | AP | 2002/07/08 | Control Supplement | 016733 | 046 | AP | 2002/04/03 | Control Supplement | 016733 | 045 | AP | 2000/04/12 | Control Supplement | 016733 | 044 | AP | 1998/03/25 | Control Supplement | 016733 | 043 | AP | 1990/09/11 | Package Change | 016733 | 041 | AP | 1988/04/19 | Control Supplement | 016733 | 039 | AP | 1985/10/10 | Labeling Revision | 016733 | 038 | AP | 1985/04/15 | Labeling Revision | 016733 | 037 | AP | 1987/03/05 | Control Supplement | 016733 | 036 | AP | 1985/04/03 | Control Supplement | 016733 | 035 | AP | 1985/05/17 | Package Change | 016733 | 033 | AP | 1985/05/24 | Control Supplement | 016733 | 032 | AP | 1981/09/24 | Package Change | 016733 | 031 | AP | 1981/09/28 | Control Supplement | 016733 | 030 | AP | 1982/03/12 | Labeling Revision | 016733 | 029 | AP | 1981/11/06 | Manufacturing Change or Addition | 016733 | 028 | AP | 1981/03/18 | Control Supplement | 016733 | 027 | AP | 1981/10/27 | Labeling Revision | 016733 | 026 | AP | 1981/10/27 | Control Supplement | 016733 | 025 | AP | 1980/07/16 | Control Supplement | 016733 | 024 | AP | 1980/02/15 | Control Supplement | 016733 | 023 | AP | 1979/09/25 | Labeling Revision | 016733 | 022 | AP | 1979/09/24 | Control Supplement | 016733 | 021 | AP | 1979/08/06 | Labeling Revision | 016733 | 020 | AP | 1980/01/04 | Labeling Revision | 016733 | 019 | AP | 1979/04/26 | Control Supplement | 016733 | 018 | AP | 1978/08/04 | Control Supplement | 016733 | 017 | AP | 1978/10/27 | Control Supplement | 016733 | 016 | AP | 1978/10/27 | Control Supplement | 016733 | 015 | AP | 1978/12/27 | Labeling Revision | 016733 | 014 | AP | 1978/12/27 | Control Supplement | 016733 | 013 | AP | 1978/05/26 | Control Supplement | 016733 | 012 | AP | 1978/03/15 | Manufacturing Change or Addition | 016733 | 011 | AP | 1978/03/30 | Labeling Revision | 016733 | 010 | AP | 1978/02/14 | Control Supplement | 016733 | 009 | AP | 1977/06/28 | Control Supplement | 016733 | 008 | AP | 1977/02/04 | Control Supplement | 016733 | 007 | AP | 1976/10/20 | Labeling Revision | 016733 | 006 | AP | 1976/04/02 | Control Supplement | 016733 | 005 | AP | 1976/04/02 | Control Supplement | 016733 | 004 | AP | 1976/04/02 | Control Supplement | 016733 | 003 | AP | 1974/08/30 | Labeling Revision | 016733 | 000 | AP | 1970/08/12 | Approval |
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