| 药品名称 | ELAVIL | | 申请号 | 012703 | 产品号 | 004 | | 活性成分 | AMITRIPTYLINE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 50MG | | 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 | ASTRAZENECA PHARMACEUTICALS LP
| | 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 | | 012703 | 093 | AP | Letter | 2003/08/06 | 下载 | | 012703 | 092 | AP | Letter | 2001/03/27 | 下载 | | 012703 | 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 | | 012703 | 093 | AP | 2003/07/29 | Labeling Revision | | 012703 | 092 | AP | 2001/03/27 | Labeling Revision | | 012703 | 091 | AP | 2001/01/22 | Control Supplement | | 012703 | 090 | AP | 2000/04/05 | Labeling Revision | | 012703 | 089 | AP | 1998/12/24 | Manufacturing Change or Addition | | 012703 | 088 | AP | 2000/04/05 | Labeling Revision | | 012703 | 087 | AP | 1996/12/30 | Package Change | | 012703 | 086 | AP | 2000/04/05 | Labeling Revision | | 012703 | 085 | AP | 1995/07/13 | Control Supplement | | 012703 | 084 | AP | 2000/04/05 | Labeling Revision | | 012703 | 083 | AP | 1994/06/01 | Formulation Revision | | 012703 | 082 | AP | 1994/06/01 | Control Supplement | | 012703 | 081 | AP | 1991/06/24 | Labeling Revision | | 012703 | 080 | AP | 1989/07/28 | Manufacturing Change or Addition | | 012703 | 079 | AP | 1991/06/24 | Labeling Revision | | 012703 | 078 | AP | 1988/04/08 | Package Change | | 012703 | 077 | AP | 1988/12/12 | Formulation Revision | | 012703 | 076 | AP | 1991/06/24 | Labeling Revision | | 012703 | 075 | AP | 1988/02/26 | Control Supplement | | 012703 | 074 | AP | 1986/04/02 | Expiration Date Change | | 012703 | 073 | AP | 1986/07/10 | Labeling Revision | | 012703 | 072 | AP | 1985/09/20 | Labeling Revision | | 012703 | 071 | AP | 1984/09/13 | Package Change | | 012703 | 070 | AP | 1984/08/15 | Package Change | | 012703 | 069 | AP | 1984/03/07 | Manufacturing Change or Addition | | 012703 | 068 | AP | 1983/03/15 | Labeling Revision | | 012703 | 067 | AP | 1983/05/26 | Manufacturing Change or Addition | | 012703 | 065 | AP | 1984/05/21 | Labeling Revision | | 012703 | 064 | AP | 1983/05/03 | Control Supplement | | 012703 | 062 | AP | 1981/06/25 | Manufacturing Change or Addition | | 012703 | 061 | AP | 1981/03/23 | Labeling Revision | | 012703 | 060 | AP | 1980/09/03 | Labeling Revision | | 012703 | 059 | AP | 1980/06/23 | Labeling Revision | | 012703 | 058 | AP | 1981/03/02 | Formulation Revision | | 012703 | 057 | AP | 1981/09/04 | Formulation Revision | | 012703 | 056 | AP | 1981/03/02 | Manufacturing Change or Addition | | 012703 | 054 | AP | 1980/03/04 | Labeling Revision | | 012703 | 053 | AP | 1980/01/29 | Labeling Revision | | 012703 | 052 | AP | 1979/11/06 | Labeling Revision | | 012703 | 050 | AP | 1981/03/02 | Manufacturing Change or Addition | | 012703 | 049 | AP | 1980/01/29 | Manufacturing Change or Addition | | 012703 | 046 | AP | 1978/01/25 | Package Change | | 012703 | 044 | AP | 1977/03/01 | Package Change | | 012703 | 043 | AP | 1976/08/02 | Control Supplement | | 012703 | 042 | AP | 1976/09/17 | Labeling Revision | | 012703 | 041 | AP | 1976/08/02 | Control Supplement | | 012703 | 039 | AP | 1976/10/28 | Labeling Revision | | 012703 | 038 | AP | 1975/09/18 | Labeling Revision | | 012703 | 037 | AP | 1975/09/18 | Labeling Revision | | 012703 | 036 | AP | 1975/09/17 | Control Supplement | | 012703 | 035 | AP | 1975/09/17 | Control Supplement | | 012703 | 032 | AP | 1981/03/09 | Control Supplement | | 012703 | 000 | AP | 1961/04/07 | Approval |
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