药品名称 | TOFRANIL-PM | 申请号 | 017090 | 产品号 | 003 | 活性成分 | IMIPRAMINE PAMOATE | 市场状态 | 停止上市 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 125MG HCL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | MALLINCKRODT INC
| 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 | 017090 | 078 | AP | Letter | 2014/07/29 | 下载![](pdf.jpg) | 017090 | 078 | AP | Label | 2014/07/29 | 下载![](pdf.jpg) | 017090 | 077 | AP | Label | 2014/07/11 | 下载![](pdf.jpg) | 017090 | 077 | AP | Letter | 2014/07/11 | 下载![](pdf.jpg) | 017090 | 076 | AP | Label | 2012/10/26 | 下载![](pdf.jpg) | 017090 | 076 | AP | Letter | 2012/10/29 | 下载![](pdf.jpg) | 017090 | 074 | AP | Label | 2007/07/16 | 下载![](pdf.jpg) | 017090 | 074 | AP | Letter | 2007/07/24 | 下载![](pdf.jpg) | 017090 | 070 | AP | Letter | 2005/01/13 | 下载![](pdf.jpg) | 017090 | 070 | AP | Label | 2005/01/13 | 下载![](pdf.jpg) | 017090 | 069 | AP | Letter | 2004/03/28 | 下载![](pdf.jpg) | 017090 | 000 | AP | Other Important Information from FDA | 2007/05/09 | 下载 | 017090 | 000 | AP | Medication Guide | 2012/10/29 | 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 | 017090 | 078 | AP | 2014/07/28 | Labeling Revision | 017090 | 077 | AP | 2014/07/10 | Labeling Revision | 017090 | 076 | AP | 2012/10/26 | Labeling Revision | 017090 | 074 | AP | 2007/07/13 | Labeling Revision | 017090 | 070 | AP | 2005/01/12 | Labeling Revision | 017090 | 069 | AP | 2004/03/26 | Labeling Revision | 017090 | 068 | AP | 2002/06/20 | Manufacturing Change or Addition | 017090 | 067 | AP | 2002/01/03 | Labeling Revision | 017090 | 066 | AP | 2000/06/21 | Manufacturing Change or Addition | 017090 | 065 | AP | 2000/04/26 | Control Supplement | 017090 | 064 | AP | 1999/04/15 | Package Change | 017090 | 063 | AP | 1997/07/31 | Control Supplement | 017090 | 062 | AP | 2000/03/27 | Labeling Revision | 017090 | 061 | AP | 2000/03/27 | Labeling Revision | 017090 | 060 | AP | 2000/03/27 | Labeling Revision | 017090 | 059 | AP | 1993/02/19 | Control Supplement | 017090 | 058 | AP | 1992/12/08 | Labeling Revision | 017090 | 057 | AP | 1991/08/02 | Control Supplement | 017090 | 056 | AP | 1990/04/05 | Package Change | 017090 | 055 | AP | 1989/10/25 | Manufacturing Change or Addition | 017090 | 054 | AP | 1989/10/25 | Manufacturing Change or Addition | 017090 | 053 | AP | 1989/08/08 | Manufacturing Change or Addition | 017090 | 052 | AP | 1989/04/07 | Package Change | 017090 | 051 | AP | 1987/08/12 | New Dosage Regimen | 017090 | 050 | AP | 1986/05/20 | Control Supplement | 017090 | 049 | AP | 1985/11/27 | Labeling Revision | 017090 | 048 | AP | 1985/05/05 | Control Supplement | 017090 | 047 | AP | 1985/04/26 | Labeling Revision | 017090 | 046 | AP | 1984/10/29 | Control Supplement | 017090 | 045 | AP | 1984/03/26 | Labeling Revision | 017090 | 044 | AP | 1984/11/05 | Control Supplement | 017090 | 042 | AP | 1983/05/04 | Package Change | 017090 | 041 | AP | 1986/07/18 | Expiration Date Change | 017090 | 040 | AP | 1981/02/04 | Labeling Revision | 017090 | 039 | AP | 1980/04/16 | Manufacturing Change or Addition | 017090 | 038 | AP | 1980/04/16 | Package Change | 017090 | 037 | AP | 1980/01/30 | Package Change | 017090 | 036 | AP | 1979/06/07 | Package Change | 017090 | 035 | AP | 1979/06/07 | Manufacturing Change or Addition | 017090 | 034 | AP | 1979/12/28 | Control Supplement | 017090 | 033 | AP | 1979/12/28 | Control Supplement | 017090 | 032 | AP | 1979/01/02 | Labeling Revision | 017090 | 025 | AP | 1977/06/07 | Control Supplement | 017090 | 023 | AP | 1975/12/03 | Control Supplement | 017090 | 019 | AP | 1974/06/03 | Control Supplement | 017090 | 017 | AP | 1974/05/28 | Control Supplement | 017090 | 016 | AP | 1974/05/28 | Control Supplement | 017090 | 015 | AP | 1974/05/28 | Control Supplement | 017090 | 014 | AP | 1974/05/28 | Control Supplement | 017090 | 013 | AP | 1974/05/28 | Control Supplement | 017090 | 012 | AP | 1974/05/28 | Control Supplement | 017090 | 010 | AP | 1974/05/22 | Other Amendment | 017090 | 009 | AP | 1974/05/22 | Other Amendment | 017090 | 008 | AP | 1974/05/22 | Other Amendment | 017090 | 007 | AP | 1974/05/22 | Other Amendment | 017090 | 006 | AP | 1974/05/22 | Other Amendment | 017090 | 000 | AP | 1973/03/11 | Approval |
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