药品名称 | NOVOLIN R | 申请号 | 019938 | 产品号 | 001 | 活性成分 | INSULIN RECOMBINANT HUMAN | 市场状态 | 非处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 100 UNITS/ML | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1991/06/25 | 申请机构 | NOVO NORDISK INC
| 化学类型 | New formulation or new manufacturer | 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 | 019938 | 074 | AP | Letter | 2016/01/11 | 下载 | 019938 | 074 | AP | Label | 2016/01/12 | 下载 | 019938 | 072 | AP | Label | 2013/02/08 | 下载 | 019938 | 072 | AP | Letter | 2013/02/08 | 下载 | 019938 | 071 | AP | Letter | 2013/03/12 | 下载 | 019938 | 071 | AP | Label | 2013/03/12 | 下载 | 019938 | 069 | AP | Letter | 2010/06/29 | 下载 | 019938 | 068 | AP | Letter | 2011/01/04 | 下载 | 019938 | 067 | AP | Letter | 2010/06/29 | 下载 | 019938 | 066 | AP | Label | 2012/02/27 | 下载 | 019938 | 066 | AP | Letter | 2012/02/29 | 下载 | 019938 | 064 | AP | Label | 2009/07/23 | 下载 | 019938 | 064 | AP | Letter | 2009/07/24 | 下载 | 019938 | 063 | AP | Letter | 2009/06/18 | 下载 | 019938 | 063 | AP | Label | 2009/06/22 | 下载 | 019938 | 048 | AP | Label | 2005/10/25 | 下载 | 019938 | 037 | AP | Label | 2005/11/22 | 下载 | 019938 | 037 | AP | Letter | 2005/11/22 | 下载 | 019938 | 033 | AP | Letter | 2002/04/15 | 下载 | 019938 | 033 | AP | Label | 2002/04/15 | 下载 | 019938 | 032 | AP | Letter | 2002/04/11 | 下载 | 019938 | 032 | AP | Label | 2002/04/11 | 下载 | 019938 | 030 | AP | Letter | 2002/03/11 | 下载 | 019938 | 030 | AP | Label | 2002/03/11 | 下载 | 019938 | 020 | AP | Review | 1997/11/20 | 下载 | 019938 | 019 | AP | Review | 1997/04/10 | 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 | 019938 | 074 | AP | 2016/01/08 | Labeling Revision | 019938 | 073 | AP | 2015/12/01 | Manufacturing Change or Addition | 019938 | 072 | AP | 2013/02/07 | Labeling Revision | 019938 | 071 | AP | 2013/03/09 | Labeling Revision | 019938 | 069 | AP | 2010/06/25 | Labeling Revision | 019938 | 068 | AP | 2010/12/27 | Labeling Revision | 019938 | 067 | AP | 2010/06/25 | Manufacturing Change or Addition | 019938 | 066 | AP | 2012/02/27 | Labeling Revision | 019938 | 064 | AP | 2009/07/17 | Control Supplement | 019938 | 063 | AP | 2009/06/15 | Labeling Revision | 019938 | 048 | AP | 2005/10/21 | Supplement | 019938 | 037 | AP | 2005/11/18 | Labeling Revision | 019938 | 036 | AP | 2002/06/19 | Manufacturing Change or Addition | 019938 | 035 | AP | 2002/01/10 | Control Supplement | 019938 | 034 | AP | 2001/12/19 | Package Change | 019938 | 033 | AP | 2002/04/15 | Package Change | 019938 | 032 | AP | 2002/04/11 | Package Change | 019938 | 031 | AP | 2001/01/09 | Control Supplement | 019938 | 030 | AP | 2002/03/11 | Labeling Revision | 019938 | 029 | AP | 2001/12/10 | Labeling Revision | 019938 | 027 | AP | 2000/06/15 | Labeling Revision | 019938 | 026 | AP | 2000/04/10 | Control Supplement | 019938 | 025 | AP | 2000/03/16 | Package Change | 019938 | 024 | AP | 1999/10/18 | Manufacturing Change or Addition | 019938 | 023 | AP | 1998/07/24 | Control Supplement | 019938 | 022 | AP | 1997/08/04 | Control Supplement | 019938 | 021 | AP | 1997/06/20 | Package Change | 019938 | 020 | AP | 1997/04/16 | Labeling Revision | 019938 | 019 | AP | 1997/04/10 | Labeling Revision | 019938 | 018 | AP | 1996/06/13 | Manufacturing Change or Addition | 019938 | 017 | AP | 1997/01/28 | Control Supplement | 019938 | 016 | AP | 1995/08/16 | Control Supplement | 019938 | 015 | AP | 1995/05/22 | Control Supplement | 019938 | 014 | AP | 1994/01/04 | Labeling Revision | 019938 | 013 | AP | 1994/01/03 | Labeling Revision | 019938 | 012 | AP | 1994/06/23 | Package Change | 019938 | 011 | AP | 1994/06/23 | Control Supplement | 019938 | 010 | AP | 1994/06/16 | Control Supplement | 019938 | 009 | AP | 1994/05/31 | Control Supplement | 019938 | 008 | AP | 1994/05/23 | Control Supplement | 019938 | 007 | AP | 1994/04/26 | Control Supplement | 019938 | 006 | AP | 1994/01/07 | Labeling Revision | 019938 | 005 | AP | 1993/03/26 | Labeling Revision | 019938 | 003 | AP | 1993/03/26 | Control Supplement | 019938 | 002 | AP | 1992/03/13 | Control Supplement | 019938 | 001 | AP | 1991/10/07 | Control Supplement | 019938 | 000 | AP | 1991/06/25 | Approval |
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