| 药品名称 | BRETHINE | | 申请号 | 017849 | 产品号 | 002 | | 活性成分 | TERBUTALINE SULFATE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 5MG | | 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 | LEHIGH VALLEY TECHNOLOGIES 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 | | 017849 | 039 | AP | Letter | 2003/12/23 | 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 | | 017849 | 040 | AP | 2011/04/08 | Labeling Revision | | 017849 | 039 | AP | 2003/12/19 | Labeling Revision | | 017849 | 038 | AP | 2002/03/04 | Manufacturing Change or Addition | | 017849 | 037 | AP | 2002/05/28 | Manufacturing Change or Addition | | 017849 | 036 | AP | 1999/04/23 | Package Change | | 017849 | 034 | AP | 1999/02/08 | Manufacturing Change or Addition | | 017849 | 033 | AP | 1997/09/09 | Control Supplement | | 017849 | 032 | AP | 1999/02/02 | Labeling Revision | | 017849 | 031 | AP | 1997/02/25 | Control Supplement | | 017849 | 030 | AP | 1997/07/07 | Manufacturing Change or Addition | | 017849 | 029 | AP | 1996/02/23 | Control Supplement | | 017849 | 028 | AP | 1995/12/18 | Package Change | | 017849 | 027 | AP | 1995/11/14 | Control Supplement | | 017849 | 026 | AP | 1995/03/24 | Control Supplement | | 017849 | 025 | AP | 1992/07/16 | Control Supplement | | 017849 | 024 | AP | 1993/02/09 | Manufacturing Change or Addition | | 017849 | 021 | AP | 1986/01/31 | Control Supplement | | 017849 | 020 | AP | 1984/05/16 | Control Supplement | | 017849 | 018 | AP | 1984/05/16 | Control Supplement | | 017849 | 017 | AP | 1984/05/16 | Package Change | | 017849 | 016 | AP | 1982/03/22 | Control Supplement | | 017849 | 015 | AP | 1981/06/06 | Control Supplement | | 017849 | 014 | AP | 1980/11/05 | Control Supplement | | 017849 | 013 | AP | 1980/02/13 | Package Change | | 017849 | 012 | AP | 1980/06/25 | Control Supplement | | 017849 | 011 | AP | 1980/06/04 | Control Supplement | | 017849 | 010 | AP | 1979/04/03 | Manufacturing Change or Addition | | 017849 | 009 | AP | 1979/04/03 | Control Supplement | | 017849 | 008 | AP | 1979/04/03 | Control Supplement | | 017849 | 007 | AP | 1979/05/24 | Labeling Revision | | 017849 | 006 | AP | 1979/01/03 | Expiration Date Change | | 017849 | 005 | AP | 1979/01/03 | Package Change | | 017849 | 003 | AP | 1977/03/08 | Control Supplement | | 017849 | 002 | AP | 1977/03/08 | Control Supplement | | 017849 | 001 | AP | 1977/03/08 | Control Supplement | | 017849 | 000 | AP | 1976/05/17 | Approval |
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