药品名称 | AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | 申请号 | 021277 | 产品号 | 001 | 活性成分 | MOXIFLOXACIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | SOLUTION;IV (INFUSION) | 规格 | 400MG/250ML (1.6MG/ML) | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2001/11/30 | 申请机构 | BAYER HEALTHCARE PHARMACEUTICALS INC
| 化学类型 | New dosage form | 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 | 021277 | 059 | AP | Label | 2016/07/26 | 下载![](pdf.jpg) | 021277 | 059 | AP | Letter | 2016/07/26 | 下载![](pdf.jpg) | 021277 | 058 | AP | Label | 2016/09/29 | 下载![](pdf.jpg) | 021277 | 058 | AP | Letter | 2016/09/30 | 下载![](pdf.jpg) | 021277 | 057 | AP | Letter | 2016/09/30 | 下载![](pdf.jpg) | 021277 | 057 | AP | Label | 2016/09/29 | 下载![](pdf.jpg) | 021277 | 056 | AP | Letter | 2015/05/13 | 下载![](pdf.jpg) | 021277 | 056 | AP | Label | 2015/06/05 | 下载![](pdf.jpg) | 021277 | 055 | AP | Letter | 2014/11/24 | 下载![](pdf.jpg) | 021277 | 055 | AP | Label | 2014/12/03 | 下载![](pdf.jpg) | 021277 | 054 | AP | Label | 2013/08/15 | 下载![](pdf.jpg) | 021277 | 054 | AP | Letter | 2013/08/16 | 下载![](pdf.jpg) | 021277 | 053 | AP | Label | 2012/12/21 | 下载![](pdf.jpg) | 021277 | 053 | AP | Letter | 2012/12/26 | 下载![](pdf.jpg) | 021277 | 052 | AP | Letter | 2012/08/28 | 下载![](pdf.jpg) | 021277 | 052 | AP | Label | 2012/09/11 | 下载![](pdf.jpg) | 021277 | 050 | AP | Label | 2011/10/20 | 下载![](pdf.jpg) | 021277 | 050 | AP | Letter | 2011/10/20 | 下载![](pdf.jpg) | 021277 | 049 | AP | Medication Guide | 2011/08/05 | 下载![](pdf.jpg) | 021277 | 049 | AP | Letter | 2011/08/08 | 下载![](pdf.jpg) | 021277 | 046 | AP | Letter | 2011/10/20 | 下载![](pdf.jpg) | 021277 | 046 | AP | Label | 2011/10/20 | 下载![](pdf.jpg) | 021277 | 041 | AP | Letter | 2011/03/02 | 下载![](pdf.jpg) | 021277 | 041 | AP | Label | 2011/03/04 | 下载![](pdf.jpg) | 021277 | 040 | AP | Label | 2010/03/05 | 下载![](pdf.jpg) | 021277 | 040 | AP | Letter | 2010/04/09 | 下载![](pdf.jpg) | 021277 | 039 | AP | Label | 2009/12/02 | 下载![](pdf.jpg) | 021277 | 039 | AP | Letter | 2010/01/25 | 下载![](pdf.jpg) | 021277 | 038 | AP | Label | 2010/10/25 | 下载![](pdf.jpg) | 021277 | 038 | AP | Letter | 2010/11/02 | 下载![](pdf.jpg) | 021277 | 036 | AP | Letter | 2009/05/05 | 下载![](pdf.jpg) | 021277 | 036 | AP | Label | 2009/05/15 | 下载![](pdf.jpg) | 021277 | 035 | AP | Letter | 2009/06/29 | 下载![](pdf.jpg) | 021277 | 034 | AP | Letter | 2008/10/07 | 下载![](pdf.jpg) | 021277 | 034 | AP | Label | 2008/10/09 | 下载![](pdf.jpg) | 021277 | 033 | AP | Letter | 2008/12/31 | 下载![](pdf.jpg) | 021277 | 033 | AP | Label | 2009/01/02 | 下载![](pdf.jpg) | 021277 | 031 | AP | Letter | 2008/02/20 | 下载![](pdf.jpg) | 021277 | 031 | AP | Label | 2008/02/25 | 下载![](pdf.jpg) | 021277 | 030 | AP | Letter | 2007/06/04 | 下载![](pdf.jpg) | 021277 | 030 | AP | Label | 2007/06/04 | 下载![](pdf.jpg) | 021277 | 025 | AP | Label | 2005/11/30 | 下载![](pdf.jpg) | 021277 | 025 | AP | Letter | 2005/11/30 | 下载![](pdf.jpg) | 021277 | 024 | AP | Letter | 2005/11/30 | 下载![](pdf.jpg) | 021277 | 024 | AP | Label | 2005/11/30 | 下载![](pdf.jpg) | 021277 | 022 | AP | Letter | 2005/06/14 | 下载![](pdf.jpg) | 021277 | 022 | AP | Label | 2005/06/14 | 下载![](pdf.jpg) | 021277 | 019 | AP | Letter | 2004/07/30 | 下载![](pdf.jpg) | 021277 | 019 | AP | Label | 2004/07/30 | 下载![](pdf.jpg) | 021277 | 018 | AP | Letter | 2004/03/10 | 下载![](pdf.jpg) | 021277 | 018 | AP | Label | 2004/04/05 | 下载![](pdf.jpg) | 021277 | 017 | AP | Letter | 2004/05/26 | 下载![](pdf.jpg) | 021277 | 017 | AP | Label | 2004/05/27 | 下载![](pdf.jpg) | 021277 | 017 | AP | Review | 2008/02/19 | 下载![](pdf.jpg) | 021277 | 011 | AP | Letter | 2003/10/06 | 下载![](pdf.jpg) | 021277 | 011 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 021277 | 009 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021277 | 009 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021277 | 007 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021277 | 007 | AP | Review | 2008/02/19 | 下载![](pdf.jpg) | 021277 | 007 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021277 | 006 | AP | Label | 2003/02/28 | 下载![](pdf.jpg) | 021277 | 006 | AP | Letter | 2003/03/10 | 下载![](pdf.jpg) | 021277 | 003 | AP | Letter | 2002/05/16 | 下载![](pdf.jpg) | 021277 | 003 | AP | Label | 2002/05/16 | 下载![](pdf.jpg) | 021277 | 002 | AP | Letter | 2002/06/12 | 下载![](pdf.jpg) | 021277 | 002 | AP | Label | 2002/06/12 | 下载![](pdf.jpg) | 021277 | 001 | AP | Letter | 2002/05/22 | 下载![](pdf.jpg) | 021277 | 000 | AP | Letter | 2001/11/30 | 下载 | 021277 | 000 | AP | Label | 2001/11/30 | 下载![](pdf.jpg) | 021277 | 000 | AP | Review | 2004/05/27 | 下载 | 021277 | 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 | 021277 | 059 | AP | 2016/07/26 | Labeling Revision | 021277 | 058 | AP | 2016/09/27 | Labeling Revision | 021277 | 057 | AP | 2016/09/27 | Efficacy Supplement with Clinical Data to Support | 021277 | 056 | AP | 2015/05/08 | Efficacy Supplement with Clinical Data to Support | 021277 | 055 | AP | 2014/11/20 | Labeling Revision | 021277 | 054 | AP | 2013/08/14 | Labeling Revision | 021277 | 053 | AP | 2012/12/18 | Labeling Revision | 021277 | 052 | AP | 2012/08/24 | Labeling Revision | 021277 | 050 | AP | 2011/10/18 | Labeling Revision | 021277 | 049 | AP | 2011/08/03 | Labeling Revision | 021277 | 046 | AP | 2011/10/18 | Labeling Revision | 021277 | 041 | AP | 2011/02/25 | Labeling Revision | 021277 | 040 | AP | 2010/03/02 | Labeling Revision | 021277 | 039 | AP | 2009/11/24 | Labeling Revision | 021277 | 038 | AP | 2010/10/25 | Labeling Revision | 021277 | 036 | AP | 2009/04/27 | Labeling Revision | 021277 | 035 | AP | 2009/06/24 | Labeling Revision | 021277 | 034 | AP | 2008/10/03 | Labeling Revision | 021277 | 033 | AP | 2008/12/29 | Labeling Revision | 021277 | 031 | AP | 2008/02/15 | Labeling Revision | 021277 | 030 | AP | 2007/05/31 | Labeling Revision | 021277 | 025 | AP | 2005/11/22 | Labeling Revision | 021277 | 024 | AP | 2005/11/22 | New or Modified Indication | 021277 | 022 | AP | 2005/06/13 | New or Modified Indication | 021277 | 019 | AP | 2004/07/28 | Labeling Revision | 021277 | 018 | AP | 2004/03/06 | Labeling Revision | 021277 | 017 | AP | 2004/05/18 | New or Modified Indication | 021277 | 011 | AP | 2003/10/06 | Labeling Revision | 021277 | 009 | AP | 2003/02/28 | Labeling Revision | 021277 | 007 | AP | 2003/02/28 | New or Modified Indication | 021277 | 006 | AP | 2003/02/28 | Labeling Revision | 021277 | 005 | AP | 2002/12/10 | Control Supplement | 021277 | 003 | AP | 2002/05/16 | Labeling Revision | 021277 | 002 | AP | 2002/06/12 | Labeling Revision | 021277 | 001 | AP | 2002/05/22 | Labeling Revision | 021277 | 000 | AP | 2001/11/30 | Approval |
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