药品名称 | DYAZIDE | 申请号 | 016042 | 产品号 | 003 | 活性成分 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 市场状态 | 处方药 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 25MG;37.5MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1994/03/03 | 申请机构 | GLAXOSMITHKLINE LLC
| 化学类型 | New combination | 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 | 016042 | 078 | AP | Letter | 2011/03/17 | 下载 | 016042 | 078 | AP | Label | 2011/03/21 | 下载 | 016042 | 077 | AP | Letter | 2010/02/26 | 下载 | 016042 | 077 | AP | Label | 2010/03/03 | 下载 | 016042 | 074 | AP | Letter | 2007/05/29 | 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 | 016042 | 078 | AP | 2011/03/15 | Labeling Revision | 016042 | 077 | AP | 2010/02/23 | Labeling Revision | 016042 | 074 | AP | 2007/05/18 | Labeling Revision | 016042 | 070 | AP | 2000/12/20 | Manufacturing Change or Addition | 016042 | 069 | AP | 2001/02/23 | Labeling Revision | 016042 | 068 | AP | 1999/03/16 | Manufacturing Change or Addition | 016042 | 067 | AP | 1998/08/31 | Manufacturing Change or Addition | 016042 | 066 | AP | 1994/12/01 | Labeling Revision | 016042 | 065 | AP | 1994/05/20 | Control Supplement | 016042 | 064 | AP | 1994/03/03 | Labeling Revision | 016042 | 062 | AP | 1992/05/01 | Control Supplement | 016042 | 061 | AP | 1991/12/02 | Formulation Revision | 016042 | 059 | AP | 1988/02/23 | Control Supplement | 016042 | 057 | AP | 1986/07/29 | Labeling Revision | 016042 | 056 | AP | 1985/03/07 | Labeling Revision | 016042 | 055 | AP | 1994/03/03 | New or Modified Indication | 016042 | 054 | AP | 1983/05/13 | Manufacturing Change or Addition | 016042 | 052 | AP | 1985/01/03 | Labeling Revision | 016042 | 051 | AP | 1982/10/08 | Labeling Revision | 016042 | 049 | AP | 1982/08/25 | Labeling Revision | 016042 | 048 | AP | 1981/10/30 | Labeling Revision | 016042 | 047 | AP | 1988/04/26 | Practioner Draft Labeling | 016042 | 046 | AP | 1982/02/23 | Labeling Revision | 016042 | 045 | AP | 1980/07/14 | Labeling Revision | 016042 | 044 | AP | 1981/01/27 | Labeling Revision | 016042 | 043 | AP | 1980/01/14 | Labeling Revision | 016042 | 041 | AP | 1979/12/06 | Labeling Revision | 016042 | 040 | AP | 1981/02/02 | Formulation Revision | 016042 | 039 | AP | 1979/09/18 | Labeling Revision | 016042 | 038 | AP | 1979/09/18 | Labeling Revision | 016042 | 037 | AP | 1979/09/18 | Labeling Revision | 016042 | 036 | AP | 1978/01/19 | Control Supplement | 016042 | 035 | AP | 1978/01/19 | Package Change | 016042 | 034 | AP | 1978/01/19 | Manufacturing Change or Addition | 016042 | 033 | AP | 1978/02/22 | Labeling Revision | 016042 | 032 | AP | 1978/02/22 | Labeling Revision | 016042 | 031 | AP | 1978/02/22 | Labeling Revision | 016042 | 030 | AP | 1978/02/22 | Labeling Revision | 016042 | 029 | AP | 1977/06/14 | Formulation Revision | 016042 | 028 | AP | 1977/02/14 | Package Change | 016042 | 027 | AP | 1977/02/14 | Package Change | 016042 | 026 | AP | 1977/04/12 | Labeling Revision | 016042 | 025 | AP | 1976/11/03 | Labeling Revision | 016042 | 024 | AP | 1976/05/21 | Labeling Revision | 016042 | 023 | AP | 1976/05/21 | Labeling Revision | 016042 | 021 | AP | 1976/01/27 | Formulation Revision | 016042 | 019 | AP | 1975/06/12 | Labeling Revision | 016042 | 018 | AP | 1976/06/23 | Labeling Revision | 016042 | 017 | AP | 1975/02/27 | Labeling Revision | 016042 | 016 | AP | 1975/02/27 | Package Change | 016042 | 014 | AP | 1976/01/27 | Other Amendment | 016042 | 008 | AP | 1976/06/23 | Other Amendment | 016042 | 000 | AP | 1965/12/02 | Approval |
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