药品名称 | TORECAN | 申请号 | 012753 | 产品号 | 001 | 活性成分 | THIETHYLPERAZINE MALEATE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 10MG | 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 | NOVARTIS PHARMACEUTICALS CORP
| 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 | 无 |
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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 | 012753 | 068 | AP | 2001/12/03 | Manufacturing Change or Addition | 012753 | 067 | AP | 2001/07/19 | Manufacturing Change or Addition | 012753 | 066 | AP | 2001/05/09 | Manufacturing Change or Addition | 012753 | 065 | AP | 2000/05/15 | Manufacturing Change or Addition | 012753 | 064 | AP | 1997/08/06 | Labeling Revision | 012753 | 063 | AP | 1996/12/02 | Control Supplement | 012753 | 062 | AP | 1995/12/07 | Manufacturing Change or Addition | 012753 | 061 | AP | 1995/10/17 | Control Supplement | 012753 | 060 | AP | 1995/02/27 | Control Supplement | 012753 | 059 | AP | 1993/07/07 | Control Supplement | 012753 | 057 | AP | 1997/08/06 | Labeling Revision | 012753 | 056 | AP | 1993/09/14 | Package Change | 012753 | 055 | AP | 1990/11/30 | Package Change | 012753 | 054 | AP | 1994/02/28 | Control Supplement | 012753 | 052 | AP | 1990/03/14 | Control Supplement | 012753 | 051 | AP | 1997/08/06 | Labeling Revision | 012753 | 050 | AP | 1990/02/23 | Package Change | 012753 | 049 | AP | 1989/08/08 | Labeling Revision | 012753 | 048 | AP | 1989/08/08 | Control Supplement | 012753 | 047 | AP | 1990/02/23 | Package Change | 012753 | 046 | AP | 1988/09/12 | Control Supplement | 012753 | 043 | AP | 1986/09/26 | Control Supplement | 012753 | 042 | AP | 1985/12/31 | Package Change | 012753 | 041 | AP | 1986/07/17 | Control Supplement | 012753 | 040 | AP | 1984/04/16 | Package Change | 012753 | 025 | AP | 1976/05/06 | Manufacturing Change or Addition | 012753 | 000 | AP | 1961/07/18 | Approval |
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