药品名称 | NORPRAMIN | 申请号 | 014399 | 产品号 | 007 | 活性成分 | DESIPRAMINE HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 10MG | 治疗等效代码 | AB | 参比药物 | 否 | 批准日期 | 1982/02/11 | 申请机构 | US PHARMACEUTICAL HOLDINGS II LLC
| 化学类型 | New active ingredient | 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 | 014399 | 069 | AP | Label | 2014/07/03 | 下载![](pdf.jpg) | 014399 | 069 | AP | Letter | 2014/07/03 | 下载![](pdf.jpg) | 014399 | 067 | AP | Label | 2012/11/26 | 下载![](pdf.jpg) | 014399 | 067 | AP | Letter | 2012/11/21 | 下载![](pdf.jpg) | 014399 | 067 | AP | Medication Guide | 2012/11/26 | 下载![](pdf.jpg) | 014399 | 066 | AP | Label | 2012/11/26 | 下载![](pdf.jpg) | 014399 | 066 | AP | Medication Guide | 2012/11/26 | 下载![](pdf.jpg) | 014399 | 066 | AP | Letter | 2012/11/21 | 下载![](pdf.jpg) | 014399 | 065 | AP | Label | 2009/10/30 | 下载![](pdf.jpg) | 014399 | 065 | AP | Medication Guide | 2009/10/30 | 下载![](pdf.jpg) | 014399 | 065 | AP | Letter | 2009/11/19 | 下载![](pdf.jpg) | 014399 | 064 | AP | Letter | 2007/07/31 | 下载![](pdf.jpg) | 014399 | 064 | AP | Label | 2007/07/31 | 下载![](pdf.jpg) | 014399 | 063 | AP | Label | 2006/04/12 | 下载![](pdf.jpg) | 014399 | 063 | AP | Letter | 2006/04/13 | 下载![](pdf.jpg) | 014399 | 062 | AP | Letter | 2005/01/13 | 下载![](pdf.jpg) | 014399 | 062 | AP | Label | 2005/01/13 | 下载![](pdf.jpg) | 014399 | 000 | AP | Other Important Information from FDA | 2007/05/09 | 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 | 014399 | 070 | AP | 2016/09/29 | Manufacturing Change or Addition | 014399 | 069 | AP | 2014/07/02 | Labeling Revision | 014399 | 068 | AP | 2014/08/07 | Manufacturing Change or Addition | 014399 | 067 | AP | 2012/11/19 | Labeling Revision | 014399 | 066 | AP | 2012/11/19 | Labeling Revision | 014399 | 065 | AP | 2009/10/26 | Labeling Revision | 014399 | 064 | AP | 2007/07/30 | Labeling Revision | 014399 | 063 | AP | 2006/04/11 | Labeling Revision | 014399 | 062 | AP | 2005/01/12 | Labeling Revision | 014399 | 061 | AP | 2000/05/23 | Labeling Revision | 014399 | 060 | AP | 2000/05/23 | Labeling Revision | 014399 | 058 | AP | 2000/05/23 | Labeling Revision | 014399 | 056 | AP | 1992/09/03 | Manufacturing Change or Addition | 014399 | 055 | AP | 2000/05/23 | Labeling Revision | 014399 | 053 | AP | 1991/12/11 | Labeling Revision | 014399 | 052 | AP | 1991/12/11 | Labeling Revision | 014399 | 051 | AP | 1989/06/19 | Manufacturing Change or Addition | 014399 | 050 | AP | 1990/04/25 | Control Supplement | 014399 | 049 | AP | 1990/12/10 | Labeling Revision | 014399 | 048 | AP | 1989/03/21 | Manufacturing Change or Addition | 014399 | 047 | AP | 1988/03/30 | Manufacturing Change or Addition | 014399 | 046 | AP | 1988/06/20 | Package Change | 014399 | 045 | AP | 1988/11/15 | Package Change | 014399 | 044 | AP | 1987/04/03 | Control Supplement | 014399 | 043 | AP | 1986/06/24 | Control Supplement | 014399 | 042 | AP | 1990/12/10 | Labeling Revision | 014399 | 040 | AP | 1985/04/29 | Labeling Revision | 014399 | 038 | AP | 1982/06/22 | Manufacturing Change or Addition | 014399 | 037 | AP | 1982/06/22 | Control Supplement | 014399 | 036 | AP | 1982/02/01 | Control Supplement | 014399 | 035 | AP | 1982/02/01 | Control Supplement | 014399 | 034 | AP | 1982/02/01 | Package Change | 014399 | 033 | AP | 1982/02/11 | Formulation Revision | 014399 | 032 | AP | 1982/02/01 | Formulation Revision | 014399 | 031 | AP | 1980/07/28 | Labeling Revision | 014399 | 030 | AP | 1980/08/18 | Labeling Revision | 014399 | 029 | AP | 1980/02/14 | Formulation Revision | 014399 | 023 | AP | 1975/10/06 | Labeling Revision | 014399 | 022 | AP | 1976/05/28 | Labeling Revision | 014399 | 021 | AP | 1975/04/15 | Control Supplement | 014399 | 020 | AP | 1976/06/25 | General Efficacy (MarkIV) | 014399 | 019 | AP | 1975/04/04 | Control Supplement | 014399 | 018 | AP | 1974/07/02 | Control Supplement | 014399 | 000 | AP | 1964/11/20 | Approval |
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