药品名称 | TRANXENE SD | 申请号 | 017105 | 产品号 | 005 | 活性成分 | CLORAZEPATE DIPOTASSIUM | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 11.25MG | 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 | RECORDATI RARE DISEASES INC
| 化学类型 | New molecular entity (NME) | 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 | 017105 | 077 | AP | Letter | 2011/07/21 | 下载![](pdf.jpg) | 017105 | 076 | AP | Label | 2010/06/14 | 下载![](pdf.jpg) | 017105 | 076 | AP | Letter | 2010/06/15 | 下载![](pdf.jpg) | 017105 | 076 | AP | Medication Guide | 2010/06/24 | 下载![](pdf.jpg) | 017105 | 075 | AP | Label | 2009/04/28 | 下载![](pdf.jpg) | 017105 | 075 | AP | Letter | 2009/04/29 | 下载![](pdf.jpg) | 017105 | 070 | AP | Letter | 2003/03/26 | 下载![](pdf.jpg) | 017105 | 070 | AP | Review | 2006/10/25 | 下载![](pdf.jpg) | 017105 | 062 | AP | Review | 2007/07/09 | 下载![](pdf.jpg) | 017105 | 062 | AP | Letter | 2002/02/07 | 下载![](pdf.jpg) | 017105 | 059 | AP | Letter | 2002/02/07 | 下载![](pdf.jpg) | 017105 | 059 | AP | Review | 2007/07/09 | 下载![](pdf.jpg) |
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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 | 017105 | 078 | AP | 2015/02/03 | Manufacturing Change or Addition | 017105 | 077 | AP | 2011/07/19 | Labeling Revision | 017105 | 076 | AP | 2010/06/07 | Labeling Revision | 017105 | 075 | AP | 2009/04/23 | Labeling Revision | 017105 | 070 | AP | 2003/03/13 | Labeling Revision | 017105 | 069 | AP | 2002/08/28 | Control Supplement | 017105 | 068 | AP | 1998/05/08 | Package Change | 017105 | 067 | AP | 1999/08/04 | Control Supplement | 017105 | 066 | AP | 1996/11/05 | Control Supplement | 017105 | 064 | AP | 1988/11/08 | Control Supplement | 017105 | 062 | AP | 2002/02/07 | Labeling Revision | 017105 | 060 | AP | 1987/11/05 | Package Change | 017105 | 059 | AP | 2002/02/07 | Labeling Revision | 017105 | 058 | AP | 1987/08/13 | Control Supplement | 017105 | 057 | AP | 1987/01/08 | Control Supplement | 017105 | 056 | AP | 1986/11/14 | Control Supplement | 017105 | 055 | AP | 1986/08/29 | Control Supplement | 017105 | 054 | AP | 1985/08/26 | Control Supplement | 017105 | 053 | AP | 1986/06/16 | Control Supplement | 017105 | 052 | AP | 1984/02/27 | Control Supplement | 017105 | 045 | AP | 1980/10/28 | Control Supplement | 017105 | 044 | AP | 1980/09/08 | Formulation Revision | 017105 | 043 | AP | 1980/07/14 | Labeling Revision | 017105 | 040 | AP | 1979/12/12 | Labeling Revision | 017105 | 039 | AP | 1981/01/29 | General Efficacy (MarkIV) | 017105 | 038 | AP | 1979/05/31 | Control Supplement | 017105 | 037 | AP | 1979/06/05 | Formulation Revision | 017105 | 036 | AP | 1979/06/07 | Manufacturing Change or Addition | 017105 | 035 | AP | 1979/06/07 | Control Supplement | 017105 | 034 | AP | 1979/06/07 | Control Supplement | 017105 | 033 | AP | 1978/12/06 | Package Change | 017105 | 032 | AP | 1978/04/17 | Formulation Revision | 017105 | 031 | AP | 1978/05/05 | Formulation Revision | 017105 | 030 | AP | 1977/10/21 | Labeling Revision | 017105 | 029 | AP | 1979/07/09 | Control Supplement | 017105 | 028 | AP | 1977/10/20 | Formulation Revision | 017105 | 025 | AP | 1976/12/21 | Manufacturing Change or Addition | 017105 | 024 | AP | 1977/01/04 | Manufacturing Change or Addition | 017105 | 023 | AP | 1976/12/21 | Manufacturing Change or Addition | 017105 | 022 | AP | 1980/03/10 | Manufacturing Change or Addition | 017105 | 021 | AP | 1976/05/07 | Formulation Revision | 017105 | 019 | AP | 1977/03/18 | Control Supplement | 017105 | 017 | AP | 1976/07/30 | Control Supplement | 017105 | 016 | AP | 1976/08/04 | Labeling Revision | 017105 | 015 | AP | 1976/08/04 | Control Supplement | 017105 | 014 | AP | 1975/09/10 | Control Supplement | 017105 | 013 | AP | 1975/11/05 | Labeling Revision | 017105 | 009 | AP | 1975/11/13 | Control Supplement | 017105 | 008 | AP | 1975/03/31 | Control Supplement | 017105 | 000 | AP | 1972/06/23 | Approval |
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