| 药品名称 | METHOTREXATE SODIUM | | 申请号 | 008085 | 产品号 | 002 | | 活性成分 | METHOTREXATE SODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 2.5MG BASE | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | DAVA PHARMACEUTICALS INC
| | 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 | | 008085 | 066 | AP | Letter | 2016/02/01 | 下载 | | 008085 | 066 | AP | Label | 2016/02/18 | 下载 | | 008085 | 058 | AP | Letter | 2006/06/02 | 下载 | | 008085 | 055 | AP | Letter | 2003/11/05 | 下载 | | 008085 | 055 | AP | Label | 2003/11/05 | 下载 | | 008085 | 054 | AP | Letter | 2002/02/20 | 下载 | | 008085 | 053 | AP | Letter | 2002/02/20 | 下载 | | 008085 | 052 | AP | Letter | 2003/11/05 | 下载 | | 008085 | 052 | AP | Label | 2003/11/05 | 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 | | 008085 | 066 | AP | 2016/01/29 | Labeling Revision | | 008085 | 065 | AP | 2015/12/02 | Manufacturing Change or Addition | | 008085 | 058 | AP | 2006/05/31 | Labeling Revision | | 008085 | 055 | AP | 2003/10/24 | Manufacturing Change or Addition | | 008085 | 054 | AP | 2002/02/20 | Labeling Revision | | 008085 | 053 | AP | 2002/02/20 | Labeling Revision | | 008085 | 052 | AP | 2003/10/24 | Labeling Revision | | 008085 | 051 | AP | 2001/05/08 | Labeling Revision | | 008085 | 050 | AP | 2000/02/09 | Package Change | | 008085 | 048 | AP | 1999/10/29 | Labeling Revision | | 008085 | 047 | AP | 1998/06/18 | Manufacturing Change or Addition | | 008085 | 046 | AP | 2000/11/08 | Labeling Revision | | 008085 | 045 | AP | 1997/05/20 | Labeling Revision | | 008085 | 040 | AP | 1990/10/05 | Control Supplement | | 008085 | 039 | AP | 1991/07/24 | Labeling Revision | | 008085 | 038 | AP | 1990/10/24 | Control Supplement | | 008085 | 036 | AP | 1989/05/18 | Control Supplement | | 008085 | 035 | AP | 1989/04/24 | Labeling Revision | | 008085 | 034 | AP | 1989/11/16 | Manufacturing Change or Addition | | 008085 | 032 | AP | 1990/01/18 | Labeling Revision | | 008085 | 031 | AP | 1986/12/08 | Manufacturing Change or Addition | | 008085 | 030 | AP | 1986/09/16 | Labeling Revision | | 008085 | 028 | AP | 1988/10/31 | New or Modified Indication | | 008085 | 027 | AP | 1988/10/31 | Package Change | | 008085 | 024 | AP | 1984/07/19 | Control Supplement | | 008085 | 023 | AP | 1984/04/04 | Control Supplement | | 008085 | 021 | AP | 1983/08/04 | Control Supplement | | 008085 | 019 | AP | 1983/02/04 | Formulation Revision | | 008085 | 017 | AP | 1979/09/05 | Formulation Revision | | 008085 | 016 | AP | 1978/07/10 | Control Supplement | | 008085 | 015 | AP | 1979/05/01 | Control Supplement | | 008085 | 014 | AP | 1977/04/29 | Labeling (MarkIV) | | 008085 | 013 | AP | 1977/04/29 | Package Change | | 008085 | 011 | AP | 1976/01/26 | Supplement | | 008085 | 000 | AP | 1953/12/07 | Approval |
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