| 药品名称 | TRAVATAN | | 申请号 | 021257 | 产品号 | 001 | | 活性成分 | TRAVOPROST | 市场状态 | 停止上市 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | 0.004% | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2001/03/16 | 申请机构 | ALCON PHARMACEUTICALS LTD
| | 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 | | 021257 | 025 | AP | Label | 2011/09/12 | 下载 | | 021257 | 025 | AP | Letter | 2011/09/12 | 下载 | | 021257 | 018 | AP | Letter | 2010/09/02 | 下载 | | 021257 | 018 | AP | Label | 2010/09/07 | 下载 | | 021257 | 015 | AP | Label | 2006/01/27 | 下载 | | 021257 | 015 | AP | Letter | 2006/01/30 | 下载 | | 021257 | 014 | AP | Letter | 2006/01/30 | 下载 | | 021257 | 014 | AP | Label | 2006/01/27 | 下载 | | 021257 | 013 | AP | Label | 2004/03/03 | 下载 | | 021257 | 013 | AP | Letter | 2004/02/27 | 下载 | | 021257 | 012 | AP | Label | 2004/03/03 | 下载 | | 021257 | 012 | AP | Letter | 2004/02/27 | 下载 | | 021257 | 010 | AP | Label | 2003/05/29 | 下载 | | 021257 | 010 | AP | Letter | 2003/06/08 | 下载 | | 021257 | 009 | AP | Label | 2003/02/13 | 下载 | | 021257 | 009 | AP | Letter | 2003/02/13 | 下载 | | 021257 | 008 | AP | Letter | 2003/02/13 | 下载 | | 021257 | 008 | AP | Label | 2003/03/05 | 下载 | | 021257 | 006 | AP | Label | 2003/02/13 | 下载 | | 021257 | 006 | AP | Letter | 2003/02/13 | 下载 | | 021257 | 000 | AP | Label | 2001/03/16 | 下载 | | 021257 | 000 | AP | Review | 2001/08/20 | 下载 | | 021257 | 000 | AP | Letter | 2004/06/28 | 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 | | 021257 | 025 | AP | 2011/09/07 | Labeling Revision | | 021257 | 018 | AP | 2010/08/31 | New or Modified Indication | | 021257 | 015 | AP | 2006/01/23 | Labeling Revision | | 021257 | 014 | AP | 2006/01/23 | Package Change | | 021257 | 013 | AP | 2004/02/20 | Labeling Revision | | 021257 | 012 | AP | 2004/02/20 | Package Change | | 021257 | 010 | AP | 2003/05/15 | Package Change | | 021257 | 009 | AP | 2003/02/13 | Labeling Revision | | 021257 | 008 | AP | 2003/02/13 | Labeling Revision | | 021257 | 007 | AP | 2002/12/04 | Manufacturing Change or Addition | | 021257 | 006 | AP | 2003/02/13 | Efficacy Supplement with Clinical Data to Support | | 021257 | 005 | AP | 2002/12/04 | Control Supplement | | 021257 | 003 | AP | 2002/08/28 | Control Supplement | | 021257 | 002 | AP | 2002/02/15 | Manufacturing Change or Addition | | 021257 | 001 | AP | 2002/03/25 | Control Supplement | | 021257 | 000 | AP | 2001/03/16 | Approval |
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