药品名称 | GLUCAGON | 申请号 | 012122 | 产品号 | 002 | 活性成分 | GLUCAGON HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 10MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ELI LILLY AND CO
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | 无 |
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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 | 012122 | 043 | AP | 1998/06/26 | Control Supplement | 012122 | 042 | AP | 1997/09/23 | Manufacturing Change or Addition | 012122 | 041 | AP | 1998/01/08 | Control Supplement | 012122 | 040 | AP | 1997/04/18 | Labeling Revision | 012122 | 039 | AP | 1997/05/12 | Labeling Revision | 012122 | 038 | AP | 1996/11/07 | Control Supplement | 012122 | 037 | AP | 1996/12/13 | Control Supplement | 012122 | 036 | AP | 1995/12/15 | Labeling Revision | 012122 | 035 | AP | 1996/04/19 | Manufacturing Change or Addition | 012122 | 034 | AP | 1993/04/28 | Labeling Revision | 012122 | 033 | AP | 1991/11/19 | Control Supplement | 012122 | 032 | AP | 1990/10/01 | Labeling Revision | 012122 | 031 | AP | 1990/10/11 | Labeling Revision | 012122 | 030 | AP | 1990/10/04 | Labeling Revision | 012122 | 029 | AP | 1988/12/02 | Labeling Revision | 012122 | 028 | AP | 1988/09/30 | Package Change | 012122 | 027 | AP | 1988/01/05 | Labeling Revision | 012122 | 026 | AP | 1991/04/03 | Manufacturing Change or Addition | 012122 | 025 | AP | 1986/09/30 | Labeling Revision | 012122 | 022 | AP | 1985/10/17 | Control Supplement | 012122 | 022 | AP | 1985/10/17 | Labeling Revision | 012122 | 019 | AP | 1984/12/13 | Labeling Revision | 012122 | 018 | AP | 1984/08/09 | Labeling Revision | 012122 | 017 | AP | 1984/08/02 | Control Supplement | 012122 | 016 | AP | 1983/07/21 | Labeling Revision | 012122 | 015 | AP | 1981/10/09 | Manufacturing Change or Addition | 012122 | 014 | AP | 1981/06/15 | General Efficacy (MarkIV) | 012122 | 013 | AP | 1980/02/21 | General Efficacy (MarkIV) | 012122 | 012 | AP | 1979/11/27 | General Efficacy (MarkIV) | 012122 | 010 | AP | 1975/12/31 | Control Supplement | 012122 | 009 | AP | 1975/01/27 | Control Supplement | 012122 | 008 | AP | 1975/05/20 | Control Supplement | 012122 | 000 | AP | 1960/11/14 | Approval |
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