| 药品名称 | CATAFLAM | | 申请号 | 020142 | 产品号 | 001 | | 活性成分 | DICLOFENAC POTASSIUM | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1993/11/24 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| | 化学类型 | New active ingredient | 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 | | 020142 | 027 | AP | Label | 2016/05/11 | 下载 | | 020142 | 027 | AP | Letter | 2016/05/12 | 下载 | | 020142 | 022 | AP | Letter | 2011/02/28 | 下载 | | 020142 | 022 | AP | Label | 2011/03/04 | 下载 | | 020142 | 021 | AP | Letter | 2011/02/28 | 下载 | | 020142 | 021 | AP | Label | 2011/03/04 | 下载 | | 020142 | 019 | AP | Letter | 2009/03/03 | 下载 | | 020142 | 019 | AP | Label | 2009/03/17 | 下载 | | 020142 | 017 | AP | Label | 2006/01/25 | 下载 | | 020142 | 017 | AP | Letter | 2006/01/30 | 下载 | | 020142 | 000 | AP | Medication Guide | 2009/11/16 | 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 | | 020142 | 027 | AP | 2016/05/09 | Labeling Revision | | 020142 | 026 | AP | 2014/11/24 | Manufacturing Change or Addition | | 020142 | 022 | AP | 2011/02/23 | Labeling Revision | | 020142 | 021 | AP | 2011/02/23 | Labeling Revision | | 020142 | 019 | AP | 2009/02/25 | Labeling Revision | | 020142 | 017 | AP | 2006/01/24 | Labeling Revision | | 020142 | 015 | AP | 2002/09/19 | Control Supplement | | 020142 | 014 | AP | 2002/03/11 | Manufacturing Change or Addition | | 020142 | 013 | AP | 2001/07/13 | Manufacturing Change or Addition | | 020142 | 012 | AP | 2000/09/15 | Manufacturing Change or Addition | | 020142 | 011 | AP | 2000/07/10 | Manufacturing Change or Addition | | 020142 | 009 | AP | 1999/04/22 | Package Change | | 020142 | 008 | AP | 1997/11/12 | Control Supplement | | 020142 | 007 | AP | 1997/05/16 | Manufacturing Change or Addition | | 020142 | 006 | AP | 2001/10/31 | Labeling Revision | | 020142 | 005 | AP | 1998/04/20 | Labeling Revision | | 020142 | 004 | AP | 1995/11/28 | Manufacturing Change or Addition | | 020142 | 003 | AP | 1995/07/28 | Labeling Revision | | 020142 | 002 | AP | 1994/07/06 | Manufacturing Change or Addition | | 020142 | 001 | AP | 1995/01/11 | Control Supplement | | 020142 | 000 | AP | 1993/11/24 | Approval |
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