| 药品名称 | IMITREX STATDOSE | | 申请号 | 020080 | 产品号 | 002 | | 活性成分 | SUMATRIPTAN SUCCINATE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;SUBCUTANEOUS | 规格 | EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 2006/02/01 | 申请机构 | GLAXOSMITHKLINE
| | 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 | | 020080 | 049 | AP | Letter | 2015/11/20 | 下载 | | 020080 | 049 | AP | Label | 2015/11/25 | 下载 | | 020080 | 048 | AP | Letter | 2015/06/12 | 下载 | | 020080 | 048 | AP | Label | 2015/06/12 | 下载 | | 020080 | 045 | AP | Letter | 2012/10/04 | 下载 | | 020080 | 045 | AP | Label | 2012/10/04 | 下载 | | 020080 | 041 | AP | Label | 2012/10/04 | 下载 | | 020080 | 041 | AP | Letter | 2012/10/04 | 下载 | | 020080 | 040 | AP | Label | 2012/10/04 | 下载 | | 020080 | 040 | AP | Letter | 2012/10/04 | 下载 | | 020080 | 039 | AP | Letter | 2012/10/04 | 下载 | | 020080 | 039 | AP | Label | 2012/10/04 | 下载 | | 020080 | 038 | AP | Letter | 2010/07/28 | 下载 | | 020080 | 038 | AP | Label | 2010/07/31 | 下载 | | 020080 | 036 | AP | Label | 2006/02/07 | 下载 | | 020080 | 036 | AP | Letter | 2006/02/08 | 下载 | | 020080 | 030 | AP | Letter | 2003/08/15 | 下载 | | 020080 | 030 | AP | Review | 2007/07/24 | 下载 | | 020080 | 029 | AP | Letter | 2004/06/07 | 下载 | | 020080 | 005 | AP | Review | 1997/11/20 | 下载 | | 020080 | 000 | AP | Other Important Information from FDA | 2007/01/17 | 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 | | 020080 | 049 | AP | 2015/11/19 | Labeling Revision | | 020080 | 048 | AP | 2015/06/11 | Labeling Revision | | 020080 | 045 | AP | 2012/10/02 | Labeling Revision | | 020080 | 041 | AP | 2012/10/02 | Labeling Revision | | 020080 | 040 | AP | 2012/10/02 | Labeling Revision | | 020080 | 039 | AP | 2012/10/02 | Labeling Revision | | 020080 | 038 | AP | 2010/07/21 | Labeling Revision | | 020080 | 036 | AP | 2006/02/01 | New Dosage Regimen | | 020080 | 030 | AP | 2003/07/28 | Labeling Revision | | 020080 | 029 | AP | 2003/01/03 | Labeling Revision | | 020080 | 027 | AP | 2001/02/02 | Labeling Revision | | 020080 | 026 | AP | 2001/02/02 | Labeling Revision | | 020080 | 025 | AP | 2001/02/02 | Labeling Revision | | 020080 | 024 | AP | 2001/02/02 | Labeling Revision | | 020080 | 023 | AP | 1997/11/26 | Control Supplement | | 020080 | 022 | AP | 1997/12/16 | Manufacturing Change or Addition | | 020080 | 021 | AP | 2001/02/02 | Labeling Revision | | 020080 | 020 | AP | 1996/03/28 | Manufacturing Change or Addition | | 020080 | 018 | AP | 1995/11/29 | Manufacturing Change or Addition | | 020080 | 017 | AP | 1995/10/05 | Control Supplement | | 020080 | 014 | AP | 1995/06/07 | Manufacturing Change or Addition | | 020080 | 005 | AP | 1996/12/23 | Package Change | | 020080 | 004 | AP | 1996/05/22 | New or Modified Indication | | 020080 | 003 | AP | 1994/08/17 | Labeling Revision | | 020080 | 002 | AP | 1993/09/30 | Manufacturing Change or Addition | | 020080 | 000 | AP | 1992/12/28 | Approval |
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