药品名称 | AVELOX | 申请号 | 021085 | 产品号 | 001 | 活性成分 | MOXIFLOXACIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 400MG BASE | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1999/12/10 | 申请机构 | BAYER HEALTHCARE PHARMACEUTICALS 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 | M-185 | 2019/09/27 | 历史市场独占权保护信息 | I-477 | 2008/06/13 | I-479 | 2008/11/18 |
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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 | 021085 | 063 | AP | Label | 2016/07/26 | 下载![](pdf.jpg) | 021085 | 063 | AP | Letter | 2016/07/26 | 下载![](pdf.jpg) | 021085 | 062 | AP | Label | 2016/09/29 | 下载![](pdf.jpg) | 021085 | 062 | AP | Letter | 2016/09/30 | 下载![](pdf.jpg) | 021085 | 061 | AP | Letter | 2016/09/30 | 下载![](pdf.jpg) | 021085 | 061 | AP | Label | 2016/09/29 | 下载![](pdf.jpg) | 021085 | 060 | AP | Letter | 2015/05/13 | 下载![](pdf.jpg) | 021085 | 060 | AP | Label | 2015/06/05 | 下载![](pdf.jpg) | 021085 | 059 | AP | Letter | 2014/11/24 | 下载![](pdf.jpg) | 021085 | 059 | AP | Label | 2014/12/03 | 下载![](pdf.jpg) | 021085 | 057 | AP | Label | 2013/08/15 | 下载![](pdf.jpg) | 021085 | 057 | AP | Letter | 2013/08/16 | 下载![](pdf.jpg) | 021085 | 056 | AP | Label | 2012/12/21 | 下载![](pdf.jpg) | 021085 | 056 | AP | Letter | 2012/12/26 | 下载![](pdf.jpg) | 021085 | 055 | AP | Letter | 2012/08/28 | 下载![](pdf.jpg) | 021085 | 055 | AP | Label | 2012/09/11 | 下载![](pdf.jpg) | 021085 | 053 | AP | Letter | 2011/10/20 | 下载![](pdf.jpg) | 021085 | 053 | AP | Label | 2011/10/20 | 下载![](pdf.jpg) | 021085 | 052 | AP | Medication Guide | 2011/08/05 | 下载![](pdf.jpg) | 021085 | 052 | AP | Letter | 2011/08/08 | 下载![](pdf.jpg) | 021085 | 050 | AP | Letter | 2011/10/20 | 下载![](pdf.jpg) | 021085 | 050 | AP | Label | 2011/10/20 | 下载![](pdf.jpg) | 021085 | 047 | AP | Letter | 2011/03/02 | 下载![](pdf.jpg) | 021085 | 047 | AP | Label | 2011/03/04 | 下载![](pdf.jpg) | 021085 | 046 | AP | Label | 2010/03/05 | 下载![](pdf.jpg) | 021085 | 046 | AP | Letter | 2010/04/09 | 下载![](pdf.jpg) | 021085 | 045 | AP | Label | 2009/12/02 | 下载![](pdf.jpg) | 021085 | 045 | AP | Letter | 2010/01/25 | 下载![](pdf.jpg) | 021085 | 044 | AP | Label | 2010/10/25 | 下载![](pdf.jpg) | 021085 | 044 | AP | Letter | 2010/11/02 | 下载![](pdf.jpg) | 021085 | 042 | AP | Letter | 2009/05/05 | 下载![](pdf.jpg) | 021085 | 042 | AP | Label | 2009/05/15 | 下载![](pdf.jpg) | 021085 | 041 | AP | Letter | 2009/06/29 | 下载![](pdf.jpg) | 021085 | 040 | AP | Letter | 2008/10/07 | 下载![](pdf.jpg) | 021085 | 040 | AP | Label | 2008/10/09 | 下载![](pdf.jpg) | 021085 | 039 | AP | Letter | 2008/12/31 | 下载![](pdf.jpg) | 021085 | 039 | AP | Label | 2009/01/02 | 下载![](pdf.jpg) | 021085 | 038 | AP | Letter | 2008/02/20 | 下载![](pdf.jpg) | 021085 | 038 | AP | Label | 2008/02/25 | 下载![](pdf.jpg) | 021085 | 036 | AP | Letter | 2007/06/04 | 下载![](pdf.jpg) | 021085 | 036 | AP | Label | 2007/06/04 | 下载![](pdf.jpg) | 021085 | 029 | AP | Letter | 2005/11/30 | 下载![](pdf.jpg) | 021085 | 029 | AP | Label | 2005/11/30 | 下载![](pdf.jpg) | 021085 | 027 | AP | Letter | 2005/11/30 | 下载![](pdf.jpg) | 021085 | 027 | AP | Label | 2005/11/30 | 下载![](pdf.jpg) | 021085 | 026 | AP | Letter | 2005/06/14 | 下载![](pdf.jpg) | 021085 | 026 | AP | Label | 2005/06/14 | 下载![](pdf.jpg) | 021085 | 024 | AP | Letter | 2004/07/30 | 下载![](pdf.jpg) | 021085 | 024 | AP | Label | 2004/07/30 | 下载![](pdf.jpg) | 021085 | 023 | AP | Letter | 2004/03/10 | 下载![](pdf.jpg) | 021085 | 023 | AP | Label | 2004/04/05 | 下载![](pdf.jpg) | 021085 | 022 | AP | Letter | 2004/05/26 | 下载![](pdf.jpg) | 021085 | 022 | AP | Label | 2004/05/27 | 下载![](pdf.jpg) | 021085 | 022 | AP | Review | 2008/02/19 | 下载![](pdf.jpg) | 021085 | 019 | AP | Letter | 2003/10/06 | 下载![](pdf.jpg) | 021085 | 019 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 021085 | 017 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021085 | 017 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021085 | 015 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021085 | 015 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021085 | 014 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021085 | 014 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021085 | 012 | AP | Letter | 2002/05/16 | 下载![](pdf.jpg) | 021085 | 012 | AP | Label | 2002/05/16 | 下载![](pdf.jpg) | 021085 | 010 | AP | Letter | 2001/04/27 | 下载![](pdf.jpg) | 021085 | 010 | AP | Label | 2001/04/27 | 下载![](pdf.jpg) | 021085 | 010 | AP | Review | 2004/05/27 | 下载 | 021085 | 007 | AP | Letter | 2002/06/12 | 下载![](pdf.jpg) | 021085 | 007 | AP | Label | 2002/06/12 | 下载![](pdf.jpg) | 021085 | 006 | AP | Letter | 2002/06/12 | 下载![](pdf.jpg) | 021085 | 006 | AP | Label | 2002/06/12 | 下载![](pdf.jpg) | 021085 | 000 | AP | Letter | 1999/12/10 | 下载![](pdf.jpg) | 021085 | 000 | AP | Label | 1999/12/10 | 下载![](pdf.jpg) | 021085 | 000 | AP | Review | 2004/05/27 | 下载 | 021085 | 000 | AP | Medication Guide | 2013/01/03 | 下载![](pdf.jpg) |
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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 | 021085 | 063 | AP | 2016/07/26 | Labeling Revision | 021085 | 062 | AP | 2016/09/27 | Labeling Revision | 021085 | 061 | AP | 2016/09/27 | Efficacy Supplement with Clinical Data to Support | 021085 | 060 | AP | 2015/05/08 | Efficacy Supplement with Clinical Data to Support | 021085 | 059 | AP | 2014/11/20 | Labeling Revision | 021085 | 058 | AP | 2014/11/19 | Manufacturing Change or Addition | 021085 | 057 | AP | 2013/08/14 | Labeling Revision | 021085 | 056 | AP | 2012/12/18 | Labeling Revision | 021085 | 055 | AP | 2012/08/24 | Labeling Revision | 021085 | 053 | AP | 2011/10/18 | Labeling Revision | 021085 | 052 | AP | 2011/08/03 | Labeling Revision | 021085 | 050 | AP | 2011/10/18 | Labeling Revision | 021085 | 047 | AP | 2011/02/25 | Labeling Revision | 021085 | 046 | AP | 2010/03/02 | Labeling Revision | 021085 | 045 | AP | 2009/11/23 | Labeling Revision | 021085 | 044 | AP | 2010/10/25 | Labeling Revision | 021085 | 042 | AP | 2009/04/27 | Labeling Revision | 021085 | 041 | AP | 2009/06/24 | Labeling Revision | 021085 | 040 | AP | 2008/10/03 | Labeling Revision | 021085 | 039 | AP | 2008/12/29 | Labeling Revision | 021085 | 038 | AP | 2008/02/15 | Labeling Revision | 021085 | 036 | AP | 2007/05/31 | Labeling Revision | 021085 | 029 | AP | 2005/11/22 | Labeling Revision | 021085 | 027 | AP | 2005/11/22 | New or Modified Indication | 021085 | 026 | AP | 2005/06/13 | New or Modified Indication | 021085 | 025 | AP | 2004/12/14 | Control Supplement | 021085 | 024 | AP | 2004/07/28 | Labeling Revision | 021085 | 023 | AP | 2004/03/06 | Labeling Revision | 021085 | 022 | AP | 2004/05/18 | New or Modified Indication | 021085 | 019 | AP | 2003/10/06 | Labeling Revision | 021085 | 017 | AP | 2003/02/28 | Labeling Revision | 021085 | 015 | AP | 2003/02/28 | New or Modified Indication | 021085 | 014 | AP | 2003/02/28 | Labeling Revision | 021085 | 013 | AP | 2002/12/10 | Control Supplement | 021085 | 012 | AP | 2002/05/16 | Labeling Revision | 021085 | 010 | AP | 2001/04/27 | Labeling Revision | 021085 | 008 | AP | 2001/02/02 | Control Supplement | 021085 | 007 | AP | 2002/06/12 | Labeling Revision | 021085 | 006 | AP | 2002/06/12 | Labeling Revision | 021085 | 005 | AP | 2001/05/17 | Labeling Revision | 021085 | 004 | AP | 2001/05/17 | Labeling Revision | 021085 | 002 | AP | 2000/04/21 | Manufacturing Change or Addition | 021085 | 001 | AP | 2000/05/04 | Labeling Revision | 021085 | 000 | AP | 1999/12/10 | Approval |
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