| 药品名称 | TAVIST-1 | | 申请号 | 017661 | 产品号 | 003 | | 活性成分 | CLEMASTINE FUMARATE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 1.34MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1992/08/21 | 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 | | 017661 | 051 | AP | 2002/02/11 | Manufacturing Change or Addition | | 017661 | 049 | AP | 1996/06/06 | Control Supplement | | 017661 | 048 | AP | 1996/10/31 | New or Modified Indication | | 017661 | 047 | AP | 1995/10/20 | Manufacturing Change or Addition | | 017661 | 046 | AP | 1995/10/17 | Control Supplement | | 017661 | 045 | AP | 1995/11/07 | Package Change | | 017661 | 044 | AP | 1994/06/08 | Control Supplement | | 017661 | 043 | AP | 1995/02/03 | Labeling Revision | | 017661 | 042 | AP | 1994/07/21 | Control Supplement | | 017661 | 041 | AP | 1993/05/21 | Package Change | | 017661 | 040 | AP | 1993/04/22 | Control Supplement | | 017661 | 038 | AP | 1992/08/07 | Labeling Revision | | 017661 | 036 | AP | 1992/07/22 | Labeling Revision | | 017661 | 035 | AP | 1991/02/21 | Control Supplement | | 017661 | 034 | AP | 1992/09/08 | Control Supplement | | 017661 | 033 | AP | 1992/04/23 | Control Supplement | | 017661 | 032 | AP | 1991/03/04 | Control Supplement | | 017661 | 031 | AP | 1992/09/04 | Package Change | | 017661 | 030 | AP | 1987/12/04 | Control Supplement | | 017661 | 028 | AP | 1986/04/16 | Control Supplement | | 017661 | 026 | AP | 1992/08/21 | OTC Labeling | | 017661 | 024 | AP | 1986/04/15 | Package Change | | 017661 | 023 | AP | 1983/03/01 | Control Supplement | | 017661 | 022 | AP | 1981/07/15 | Control Supplement | | 017661 | 021 | AP | 1981/07/17 | Manufacturing Change or Addition | | 017661 | 019 | AP | 1980/05/01 | Control Supplement | | 017661 | 018 | AP | 1980/04/01 | Control Supplement | | 017661 | 017 | AP | 1980/04/17 | Control Supplement | | 017661 | 016 | AP | 1979/04/20 | Labeling Revision | | 017661 | 015 | AP | 1979/04/20 | Control Supplement | | 017661 | 014 | AP | 1980/10/14 | Control Supplement | | 017661 | 013 | AP | 1978/08/17 | Control Supplement | | 017661 | 012 | AP | 1978/08/11 | Control Supplement | | 017661 | 011 | AP | 1978/08/14 | Labeling Revision | | 017661 | 010 | AP | 1978/08/14 | Control Supplement | | 017661 | 009 | AP | 1978/05/30 | Control Supplement | | 017661 | 008 | AP | 1978/05/30 | Control Supplement | | 017661 | 007 | AP | 1978/05/24 | Labeling Revision | | 017661 | 006 | AP | 1979/03/16 | Labeling Revision | | 017661 | 005 | AP | 1979/03/16 | General Efficacy (MarkIV) | | 017661 | 004 | AP | 1978/02/16 | Labeling Revision | | 017661 | 003 | AP | 1978/02/16 | Formulation Revision | | 017661 | 002 | AP | 1979/03/16 | Formulation Revision | | 017661 | 000 | AP | 1977/02/25 | Approval |
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