| 药品名称 | SEPTRA | | 申请号 | 017598 | 产品号 | 001 | | 活性成分 | SULFAMETHOXAZOLE; TRIMETHOPRIM | 市场状态 | 停止上市 | | 剂型或给药途径 | SUSPENSION;ORAL | 规格 | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | MONARCH PHARMACEUTICALS INC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 | | 017598 | 041 | AP | Label | 2007/09/11 | 下载 | | 017598 | 041 | AP | Letter | 2007/09/25 | 下载 | | 017598 | 040 | AP | Label | 2008/03/13 | 下载 | | 017598 | 040 | AP | Letter | 2008/03/13 | 下载 | | 017598 | 039 | AP | Letter | 2005/08/03 | 下载 | | 017598 | 039 | AP | Label | 2005/08/03 | 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 | | 017598 | 041 | AP | 2007/09/10 | Labeling Revision | | 017598 | 040 | AP | 2008/03/11 | Labeling Revision | | 017598 | 039 | AP | 2005/07/28 | Labeling Revision | | 017598 | 038 | AP | 2000/02/17 | Manufacturing Change or Addition | | 017598 | 037 | AP | 1997/02/13 | Labeling Revision | | 017598 | 036 | AP | 1997/03/19 | Labeling Revision | | 017598 | 033 | AP | 1996/09/11 | Labeling Revision | | 017598 | 032 | AP | 1994/01/07 | Labeling Revision | | 017598 | 031 | AP | 1993/02/22 | Manufacturing Change or Addition | | 017598 | 030 | AP | 1991/03/06 | Control Supplement | | 017598 | 029 | AP | 1991/03/06 | Control Supplement | | 017598 | 028 | AP | 1990/06/15 | New or Modified Indication | | 017598 | 027 | AP | 1992/12/01 | Control Supplement | | 017598 | 026 | AP | 1997/03/19 | Labeling Revision | | 017598 | 024 | AP | 1988/08/08 | Package Change | | 017598 | 023 | AP | 1997/03/19 | Labeling Revision | | 017598 | 022 | AP | 1988/09/09 | Labeling Revision | | 017598 | 021 | AP | 1990/11/09 | Labeling Revision | | 017598 | 020 | AP | 1986/02/12 | Formulation Revision | | 017598 | 019 | AP | 1987/08/11 | Labeling Revision | | 017598 | 018 | AP | 1984/12/11 | Formulation Revision | | 017598 | 017 | AP | 1984/11/01 | Practioner Draft Labeling | | 017598 | 016 | AP | 1982/04/27 | Labeling Revision | | 017598 | 015 | AP | 1982/03/22 | Package Change | | 017598 | 014 | AP | 1981/07/16 | Package Change | | 017598 | 013 | AP | 1981/01/13 | Package Change | | 017598 | 012 | AP | 1980/10/31 | Labeling Revision | | 017598 | 011 | AP | 1979/12/18 | Control Supplement | | 017598 | 010 | AP | 1979/07/26 | Labeling Revision | | 017598 | 008 | AP | 1977/08/26 | Package Change | | 017598 | 007 | AP | 1978/10/11 | General Efficacy (MarkIV) | | 017598 | 006 | AP | 1976/11/12 | Formulation Revision | | 017598 | 005 | AP | 1978/03/01 | General Efficacy (MarkIV) | | 017598 | 004 | AP | 1976/12/27 | Labeling Revision | | 017598 | 003 | AP | 1976/06/01 | Labeling Revision | | 017598 | 002 | AP | 1975/09/17 | Control Supplement | | 017598 | 001 | AP | 1975/09/17 | Labeling Revision | | 017598 | 000 | AP | 1975/05/31 | Approval |
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