| 药品名称 | PATANOL | | 申请号 | 020688 | 产品号 | 001 | | 活性成分 | OLOPATADINE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | EQ 0.1% BASE | | 治疗等效代码 | AT | 参比药物 | 是 | | 批准日期 | 1996/12/18 | 申请机构 | ALCON LABORATORIES INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard 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 | | 020688 | 016 | AP | Label | 2003/05/29 | 下载 | | 020688 | 016 | AP | Letter | 2003/05/29 | 下载 | | 020688 | 013 | AP | Review | 2008/08/04 | 下载 | | 020688 | 012 | AP | Letter | 2000/03/20 | 下载 | | 020688 | 011 | AP | Review | 2008/08/04 | 下载 | | 020688 | 010 | AP | Review | 2008/08/08 | 下载 | | 020688 | 009 | AP | Review | 2008/08/08 | 下载 | | 020688 | 008 | AP | Review | 2008/08/08 | 下载 | | 020688 | 006 | AP | Review | 2008/08/08 | 下载 | | 020688 | 004 | AP | Review | 2008/08/08 | 下载 | | 020688 | 003 | AP | Review | 2008/08/08 | 下载 | | 020688 | 002 | AP | Review | 2008/08/08 | 下载 | | 020688 | 001 | AP | Review | 2008/08/08 | 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 | | 020688 | 029 | AP | 2016/08/19 | Manufacturing Change or Addition | | 020688 | 028 | AP | 2015/06/30 | Manufacturing Change or Addition | | 020688 | 025 | AP | 2013/09/12 | Manufacturing Change or Addition | | 020688 | 016 | AP | 2003/04/17 | Labeling Revision | | 020688 | 015 | AP | 2002/03/13 | Control Supplement | | 020688 | 014 | AP | 2001/08/24 | Package Change | | 020688 | 013 | AP | 2001/03/16 | Control Supplement | | 020688 | 012 | AP | 2000/03/20 | New or Modified Indication | | 020688 | 011 | AP | 2000/02/18 | Manufacturing Change or Addition | | 020688 | 010 | AP | 1999/08/17 | Control Supplement | | 020688 | 009 | AP | 1999/09/28 | Control Supplement | | 020688 | 008 | AP | 1999/02/16 | Manufacturing Change or Addition | | 020688 | 007 | AP | 1999/02/05 | Manufacturing Change or Addition | | 020688 | 006 | AP | 1999/03/11 | Control Supplement | | 020688 | 005 | AP | 1998/10/14 | Control Supplement | | 020688 | 004 | AP | 1999/08/19 | Package Change | | 020688 | 003 | AP | 1998/05/29 | Labeling Revision | | 020688 | 002 | AP | 1998/09/04 | Expiration Date Change | | 020688 | 001 | AP | 1998/01/15 | Manufacturing Change or Addition | | 020688 | 000 | AP | 1996/12/18 | Approval |
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