药品名称 | BSS PLUS | 申请号 | 018469 | 产品号 | 001 | 活性成分 | CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | 市场状态 | 处方药 | 剂型或给药途径 | SOLUTION;IRRIGATION | 规格 | 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | 治疗等效代码 | AT | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ALCON LABORATORIES INC
| 化学类型 | New dosage form | 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 | 018469 | 056 | AP | Letter | 2016/04/28 | 下载 | 018469 | 056 | AP | Label | 2016/06/17 | 下载 | 018469 | 055 | AP | Label | 2015/11/12 | 下载 | 018469 | 055 | AP | Letter | 2015/12/22 | 下载 | 018469 | 054 | AP | Letter | 2015/12/22 | 下载 | 018469 | 054 | AP | Label | 2015/11/12 | 下载 | 018469 | 052 | AP | Label | 2015/05/14 | 下载 | 018469 | 041 | AP | Label | 2004/12/30 | 下载 | 018469 | 041 | AP | Letter | 2004/12/30 | 下载 | 018469 | 040 | AP | Label | 2004/12/30 | 下载 | 018469 | 040 | AP | Letter | 2004/12/30 | 下载 | 018469 | 039 | AP | Label | 2004/05/27 | 下载 | 018469 | 039 | AP | Letter | 2004/05/27 | 下载 | 018469 | 038 | AP | Label | 2004/05/27 | 下载 | 018469 | 038 | AP | Letter | 2004/05/27 | 下载 | 018469 | 037 | AP | Letter | 2003/07/28 | 下载 | 018469 | 036 | AP | Letter | 2003/07/28 | 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 | 018469 | 056 | AP | 2016/04/27 | Labeling Revision | 018469 | 055 | AP | 2015/11/06 | Manufacturing Change or Addition | 018469 | 054 | AP | 2015/11/06 | Labeling Revision | 018469 | 053 | AP | 2015/02/09 | Manufacturing Change or Addition | 018469 | 052 | AP | 2013/05/29 | Manufacturing Change or Addition | 018469 | 041 | AP | 2004/12/20 | Labeling Revision | 018469 | 040 | AP | 2004/12/20 | Package Change | 018469 | 039 | AP | 2004/05/25 | Package Change | 018469 | 038 | AP | 2004/05/25 | Labeling Revision | 018469 | 037 | AP | 2003/07/16 | Labeling Revision | 018469 | 036 | AP | 2003/07/16 | Package Change | 018469 | 035 | AP | 1999/10/18 | Control Supplement | 018469 | 034 | AP | 1998/03/20 | Manufacturing Change or Addition | 018469 | 033 | AP | 1997/11/03 | Control Supplement | 018469 | 032 | AP | 1998/12/29 | Labeling Revision | 018469 | 031 | AP | 1997/05/02 | Control Supplement | 018469 | 030 | AP | 1997/01/14 | Control Supplement | 018469 | 029 | AP | 1994/07/13 | Labeling Revision | 018469 | 028 | AP | 1994/08/19 | Manufacturing Change or Addition | 018469 | 027 | AP | 1993/06/08 | Labeling Revision | 018469 | 026 | AP | 1991/12/30 | Control Supplement | 018469 | 025 | AP | 1992/03/23 | Control Supplement | 018469 | 024 | AP | 1990/06/29 | Control Supplement | 018469 | 023 | AP | 1993/06/15 | Manufacturing Change or Addition | 018469 | 021 | AP | 1990/06/29 | Labeling Revision | 018469 | 019 | AP | 1989/10/24 | Package Change | 018469 | 018 | AP | 1988/11/08 | Package Change | 018469 | 017 | AP | 1993/03/24 | Control Supplement | 018469 | 016 | AP | 1988/11/30 | Package Change | 018469 | 015 | AP | 1988/09/30 | Control Supplement | 018469 | 014 | AP | 1988/11/17 | Labeling Revision | 018469 | 013 | AP | 1988/06/08 | Package Change | 018469 | 012 | AP | 1987/09/10 | Package Change | 018469 | 011 | AP | 1986/09/29 | Control Supplement | 018469 | 010 | AP | 1987/03/27 | Control Supplement | 018469 | 008 | AP | 1986/02/13 | Package Change | 018469 | 007 | AP | 1985/10/22 | Control Supplement | 018469 | 006 | AP | 1985/06/17 | Control Supplement | 018469 | 005 | AP | 1986/01/24 | Package Change | 018469 | 004 | AP | 1983/11/14 | Control Supplement | 018469 | 003 | AP | 1982/06/08 | Manufacturing Change or Addition | 018469 | 002 | AP | 1982/06/08 | Control Supplement | 018469 | 001 | AP | 1982/02/25 | Package Change | 018469 | 000 | AP | 1981/10/28 | Approval |
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