| 药品名称 | LEVEMIR | | 申请号 | 021536 | 产品号 | 001 | | 活性成分 | INSULIN DETEMIR RECOMBINANT | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;SUBCUTANEOUS | 规格 | 1000 UNITS/10ML (100 UNITS/ML) | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2005/06/16 | 申请机构 | NOVO NORDISK 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 | | I-489 | 2008/10/19 | | M-115 | 2015/04/06 | | M-117 | 2015/05/18 | | NCE | 2010/06/16 |
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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 | | 021536 | 051 | AP | Letter | 2015/02/27 | 下载 | | 021536 | 051 | AP | Label | 2015/03/03 | 下载 | | 021536 | 050 | AP | Letter | 2015/01/26 | 下载 | | 021536 | 050 | AP | Label | 2015/02/13 | 下载 | | 021536 | 048 | AP | Letter | 2014/02/27 | 下载 | | 021536 | 044 | AP | Letter | 2013/04/16 | 下载 | | 021536 | 044 | AP | Label | 2013/04/16 | 下载 | | 021536 | 041 | AP | Label | 2012/05/22 | 下载 | | 021536 | 041 | AP | Letter | 2012/05/22 | 下载 | | 021536 | 039 | AP | Label | 2012/05/01 | 下载 | | 021536 | 039 | AP | Letter | 2012/05/02 | 下载 | | 021536 | 037 | AP | Label | 2012/03/29 | 下载 | | 021536 | 037 | AP | Letter | 2012/04/02 | 下载 | | 021536 | 035 | AP | Letter | 2013/03/12 | 下载 | | 021536 | 035 | AP | Label | 2013/03/12 | 下载 | | 021536 | 033 | AP | Letter | 2013/11/07 | 下载 | | 021536 | 033 | AP | Label | 2013/11/19 | 下载 | | 021536 | 033 | AP | Review | 2014/08/01 | 下载 | | 021536 | 031 | AP | Letter | 2015/02/27 | 下载 | | 021536 | 031 | AP | Label | 2015/03/03 | 下载 | | 021536 | 029 | AP | Label | 2012/01/30 | 下载 | | 021536 | 029 | AP | Letter | 2012/02/01 | 下载 | | 021536 | 028 | AP | Label | 2012/11/05 | 下载 | | 021536 | 028 | AP | Letter | 2012/11/07 | 下载 | | 021536 | 024 | AP | Letter | 2009/05/13 | 下载 | | 021536 | 021 | AP | Letter | 2008/09/09 | 下载 | | 021536 | 020 | AP | Letter | 2008/09/09 | 下载 | | 021536 | 015 | AP | Review | 2011/10/28 | 下载 | | 021536 | 015 | AP | Letter | 2007/05/29 | 下载 | | 021536 | 015 | AP | Label | 2007/05/29 | 下载 | | 021536 | 000 | AP | Letter | 2005/06/21 | 下载 | | 021536 | 000 | AP | Label | 2005/06/21 | 下载 | | 021536 | 000 | AP | Review | 2005/07/26 | 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 | | 021536 | 053 | AP | 2016/08/11 | Manufacturing Change or Addition | | 021536 | 051 | AP | 2015/02/25 | Labeling Revision | | 021536 | 050 | AP | 2015/01/23 | Labeling Revision | | 021536 | 048 | AP | 2014/02/25 | Labeling Revision | | 021536 | 047 | AP | 2014/06/10 | Manufacturing Change or Addition | | 021536 | 046 | AP | 2014/03/04 | Manufacturing Change or Addition | | 021536 | 045 | AP | 2013/02/15 | Manufacturing Change or Addition | | 021536 | 044 | AP | 2013/04/10 | Labeling Revision | | 021536 | 041 | AP | 2012/05/18 | Efficacy Supplement with Clinical Data to Support | | 021536 | 039 | AP | 2012/04/27 | Efficacy Supplement with Clinical Data to Support | | 021536 | 037 | AP | 2012/03/29 | Efficacy Supplement with Clinical Data to Support | | 021536 | 035 | AP | 2013/03/09 | Labeling Revision | | 021536 | 033 | AP | 2013/10/31 | Labeling Revision | | 021536 | 031 | AP | 2015/02/25 | Labeling Revision | | 021536 | 029 | AP | 2012/01/30 | Labeling Revision | | 021536 | 028 | AP | 2012/11/05 | Labeling Revision | | 021536 | 024 | AP | 2009/05/07 | Labeling Revision | | 021536 | 023 | AP | 2008/11/28 | Labeling Revision | | 021536 | 021 | AP | 2008/09/03 | Labeling Revision | | 021536 | 020 | AP | 2008/09/03 | Labeling Revision | | 021536 | 015 | AP | 2007/05/16 | Formulation Revision | | 021536 | 000 | AP | 2005/06/16 | Approval |
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