| 药品名称 | MYAMBUTOL | | 申请号 | 016320 | 产品号 | 003 | | 活性成分 | ETHAMBUTOL HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 400MG | | 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 | STI PHARMA LLC
| | 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 | | 016320 | 066 | AP | Label | 2013/02/26 | 下载 | | 016320 | 063 | AP | Letter | 2008/11/03 | 下载 | | 016320 | 063 | AP | Label | 2008/11/07 | 下载 | | 016320 | 060 | AP | Letter | 2004/03/28 | 下载 | | 016320 | 060 | AP | Label | 2004/04/05 | 下载 | | 016320 | 058 | AP | Letter | 2003/02/06 | 下载 | | 016320 | 058 | AP | Label | 2003/02/06 | 下载 | | 016320 | 057 | AP | Label | 2003/02/06 | 下载 | | 016320 | 057 | AP | Letter | 2003/02/06 | 下载 | | 016320 | 056 | AP | Label | 2003/06/10 | 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 | | 016320 | 066 | AP | 2013/02/22 | Manufacturing Change or Addition | | 016320 | 063 | AP | 2008/10/30 | Package Change | | 016320 | 060 | AP | 2004/03/24 | Labeling Revision | | 016320 | 058 | AP | 2003/02/06 | Labeling Revision | | 016320 | 057 | AP | 2003/02/06 | Labeling Revision | | 016320 | 056 | AP | 2001/10/10 | Labeling Revision | | 016320 | 055 | AP | 1998/05/14 | Control Supplement | | 016320 | 054 | AP | 1998/05/08 | Package Change | | 016320 | 053 | AP | 1995/06/20 | Control Supplement | | 016320 | 052 | AP | 1987/11/02 | Expiration Date Change | | 016320 | 051 | AP | 1987/11/23 | Control Supplement | | 016320 | 050 | AP | 1987/05/19 | Formulation Revision | | 016320 | 049 | AP | 1986/01/03 | Control Supplement | | 016320 | 047 | AP | 1985/09/12 | Control Supplement | | 016320 | 046 | AP | 1987/06/25 | Labeling Revision | | 016320 | 044 | AP | 1982/02/24 | Control Supplement | | 016320 | 043 | AP | 1981/11/03 | Manufacturing Change or Addition | | 016320 | 042 | AP | 1981/08/18 | Expiration Date Change | | 016320 | 041 | AP | 1981/08/18 | Control Supplement | | 016320 | 040 | AP | 1981/07/29 | Control Supplement | | 016320 | 039 | AP | 1981/01/09 | Manufacturing Change or Addition | | 016320 | 038 | AP | 1979/04/03 | Control Supplement | | 016320 | 037 | AP | 1979/04/03 | Manufacturing Change or Addition | | 016320 | 036 | AP | 1978/12/21 | Labeling Revision | | 016320 | 035 | AP | 1978/06/26 | Control Supplement | | 016320 | 034 | AP | 1978/06/27 | Control Supplement | | 016320 | 033 | AP | 1978/05/03 | Manufacturing Change or Addition | | 016320 | 032 | AP | 1978/04/07 | Control Supplement | | 016320 | 031 | AP | 1977/07/05 | Formulation Revision | | 016320 | 030 | AP | 1977/05/13 | Control Supplement | | 016320 | 029 | AP | 1976/06/10 | Control Supplement | | 016320 | 028 | AP | 1976/04/28 | Control Supplement | | 016320 | 027 | AP | 1975/02/21 | Control Supplement | | 016320 | 000 | AP | 1967/11/06 | Approval |
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