| 药品名称 | XALATAN | | 申请号 | 020597 | 产品号 | 001 | | 活性成分 | LATANOPROST | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | 0.005% | | 治疗等效代码 | AT | 参比药物 | 是 | | 批准日期 | 1996/06/05 | 申请机构 | PHARMACIA AND UPJOHN CO
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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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 | | 020597 | 048 | AP | Letter | 2014/11/28 | 下载 | | 020597 | 048 | AP | Label | 2014/12/03 | 下载 | | 020597 | 046 | AP | Label | 2013/03/15 | 下载 | | 020597 | 045 | AP | Letter | 2014/11/28 | 下载 | | 020597 | 045 | AP | Label | 2014/12/03 | 下载 | | 020597 | 044 | AP | Letter | 2012/03/15 | 下载 | | 020597 | 044 | AP | Label | 2012/03/16 | 下载 | | 020597 | 036 | AP | Letter | 2010/09/07 | 下载 | | 020597 | 036 | AP | Label | 2010/09/07 | 下载 | | 020597 | 035 | AP | Label | 2010/09/07 | 下载 | | 020597 | 035 | AP | Letter | 2010/09/07 | 下载 | | 020597 | 029 | AP | Letter | 2003/07/28 | 下载 | | 020597 | 028 | AP | Letter | 2003/07/28 | 下载 | | 020597 | 026 | AP | Review | 2012/01/27 | 下载 | | 020597 | 025 | AP | Letter | 2002/08/26 | 下载 | | 020597 | 025 | AP | Label | 2002/08/26 | 下载 | | 020597 | 023 | AP | Label | 2003/04/28 | 下载 | | 020597 | 019 | AP | Label | 2003/04/28 | 下载 | | 020597 | 013 | AP | Review | 2012/01/27 | 下载 | | 020597 | 011 | AP | Review | 2012/01/27 | 下载 | | 020597 | 010 | AP | Label | 2003/04/04 | 下载 | | 020597 | 010 | AP | Letter | 2003/04/04 | 下载 | | 020597 | 005 | AP | Review | 2012/01/27 | 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 | | 020597 | 049 | AP | 2014/04/03 | Manufacturing Change or Addition | | 020597 | 048 | AP | 2014/11/25 | Labeling Revision | | 020597 | 046 | AP | 2013/03/13 | Manufacturing Change or Addition | | 020597 | 045 | AP | 2014/11/25 | Labeling Revision | | 020597 | 044 | AP | 2012/03/13 | Labeling Revision | | 020597 | 036 | AP | 2010/08/31 | Labeling Revision | | 020597 | 035 | AP | 2010/08/31 | Labeling Revision | | 020597 | 029 | AP | 2003/07/14 | Control Supplement | | 020597 | 028 | AP | 2003/07/14 | Labeling Revision | | 020597 | 026 | AP | 2002/11/15 | Manufacturing Change or Addition | | 020597 | 025 | AP | 2002/08/26 | Package Change | | 020597 | 024 | AP | 2002/06/21 | Package Change | | 020597 | 023 | AP | 2001/11/26 | Control Supplement | | 020597 | 022 | AP | 2001/05/14 | Package Change | | 020597 | 020 | AP | 2001/04/23 | Control Supplement | | 020597 | 019 | AP | 2001/08/08 | Labeling Revision | | 020597 | 018 | AP | 2000/08/25 | Labeling Revision | | 020597 | 017 | AP | 2000/12/11 | Control Supplement | | 020597 | 016 | AP | 2000/11/09 | Package Change | | 020597 | 014 | AP | 2000/12/26 | Labeling Revision | | 020597 | 013 | AP | 2000/06/02 | Manufacturing Change or Addition | | 020597 | 012 | AP | 1999/10/08 | Labeling Revision | | 020597 | 011 | AP | 2000/01/24 | Manufacturing Change or Addition | | 020597 | 010 | AP | 2002/12/20 | New or Modified Indication | | 020597 | 008 | AP | 1999/07/16 | Labeling Revision | | 020597 | 007 | AP | 1999/03/22 | Labeling Revision | | 020597 | 006 | AP | 1998/11/01 | Package Change | | 020597 | 005 | AP | 1998/07/31 | Manufacturing Change or Addition | | 020597 | 002 | AP | 1998/12/09 | Control Supplement | | 020597 | 001 | AP | 1998/06/23 | Labeling Revision | | 020597 | 000 | AP | 1996/06/05 | Approval |
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