| 药品名称 | NOVOLOG MIX 70/30 | | 申请号 | 021172 | 产品号 | 001 | | 活性成分 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;SUBCUTANEOUS | 规格 | 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2001/11/01 | 申请机构 | NOVO NORDISK INC
| | 化学类型 | New combination | 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 | | M-48 | 2008/11/21 |
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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 | | 021172 | 064 | AP | Letter | 2015/04/20 | 下载 | | 021172 | 064 | AP | Label | 2015/04/22 | 下载 | | 021172 | 063 | AP | Letter | 2015/02/27 | 下载 | | 021172 | 063 | AP | Label | 2015/03/03 | 下载 | | 021172 | 053 | AP | Letter | 2013/03/12 | 下载 | | 021172 | 053 | AP | Label | 2013/03/12 | 下载 | | 021172 | 051 | AP | Label | 2012/12/18 | 下载 | | 021172 | 051 | AP | Letter | 2012/12/19 | 下载 | | 021172 | 049 | AP | Letter | 2010/05/12 | 下载 | | 021172 | 049 | AP | Label | 2010/05/17 | 下载 | | 021172 | 046 | AP | Letter | 2015/02/27 | 下载 | | 021172 | 046 | AP | Label | 2015/03/03 | 下载 | | 021172 | 045 | AP | Letter | 2010/05/12 | 下载 | | 021172 | 045 | AP | Label | 2010/05/17 | 下载 | | 021172 | 044 | AP | Letter | 2009/05/13 | 下载 | | 021172 | 043 | AP | Letter | 2008/11/28 | 下载 | | 021172 | 039 | AP | Letter | 2008/09/09 | 下载 | | 021172 | 038 | AP | Letter | 2008/09/09 | 下载 | | 021172 | 034 | AP | Letter | 2007/07/24 | 下载 | | 021172 | 034 | AP | Label | 2007/07/24 | 下载 | | 021172 | 023 | AP | Letter | 2005/11/18 | 下载 | | 021172 | 023 | AP | Label | 2005/11/18 | 下载 | | 021172 | 021 | AP | Label | 2005/11/30 | 下载 | | 021172 | 021 | AP | Letter | 2005/11/30 | 下载 | | 021172 | 013 | AP | Letter | 2004/10/15 | 下载 | | 021172 | 013 | AP | Label | 2004/10/15 | 下载 | | 021172 | 009 | AP | Letter | 2002/11/18 | 下载 | | 021172 | 009 | AP | Label | 2002/11/18 | 下载 | | 021172 | 003 | AP | Letter | 2002/06/26 | 下载 | | 021172 | 003 | AP | Label | 2002/06/26 | 下载 | | 021172 | 001 | AP | Letter | 2002/05/03 | 下载 | | 021172 | 001 | AP | Label | 2002/05/03 | 下载 | | 021172 | 000 | AP | Letter | 2001/11/01 | 下载 | | 021172 | 000 | AP | Label | 2001/11/01 | 下载 | | 021172 | 000 | AP | Review | 2001/11/01 | 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 | | 021172 | 064 | AP | 2015/04/17 | Labeling Revision | | 021172 | 063 | AP | 2015/02/25 | Labeling Revision | | 021172 | 061 | AP | 2014/09/04 | Manufacturing Change or Addition | | 021172 | 053 | AP | 2013/03/09 | Labeling Revision | | 021172 | 051 | AP | 2012/12/13 | Labeling Revision | | 021172 | 049 | AP | 2010/05/07 | Efficacy Supplement with Clinical Data to Support | | 021172 | 046 | AP | 2015/02/25 | Labeling Revision | | 021172 | 045 | AP | 2010/05/07 | New Dosage Regimen | | 021172 | 044 | AP | 2009/05/07 | Labeling Revision | | 021172 | 043 | AP | 2008/11/28 | Labeling Revision | | 021172 | 039 | AP | 2008/09/03 | Labeling Revision | | 021172 | 038 | AP | 2008/09/03 | Labeling Revision | | 021172 | 034 | AP | 2007/07/20 | Formulation Revision | | 021172 | 023 | AP | 2005/11/15 | Labeling Revision | | 021172 | 021 | AP | 2005/11/21 | Efficacy Supplement with Clinical Data to Support | | 021172 | 013 | AP | 2004/10/08 | Labeling Revision | | 021172 | 011 | AP | 2002/12/04 | Control Supplement | | 021172 | 010 | AP | 2002/11/19 | Control Supplement | | 021172 | 009 | AP | 2002/11/18 | Package Change | | 021172 | 008 | AP | 2002/07/29 | Control Supplement | | 021172 | 007 | AP | 2002/03/05 | Control Supplement | | 021172 | 006 | AP | 2002/02/25 | Manufacturing Change or Addition | | 021172 | 005 | AP | 2002/02/25 | Control Supplement | | 021172 | 004 | AP | 2002/02/25 | Manufacturing Change or Addition | | 021172 | 003 | AP | 2002/06/26 | Formulation Revision | | 021172 | 002 | AP | 2002/02/25 | Manufacturing Change or Addition | | 021172 | 001 | AP | 2002/05/03 | Package Change | | 021172 | 000 | AP | 2001/11/01 | Approval |
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