| 药品名称 | LAMISIL | | 申请号 | 020192 | 产品号 | 001 | | 活性成分 | TERBINAFINE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | CREAM;TOPICAL | 规格 | 1% | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1992/12/30 | 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 | | 020192 | 014 | AP | Review | 2008/02/19 | 下载 | | 020192 | 013 | AP | Review | 2008/02/19 | 下载 | | 020192 | 012 | AP | Review | 2008/02/19 | 下载 | | 020192 | 011 | AP | Review | 2008/02/19 | 下载 | | 020192 | 006 | AP | Review | 2008/02/19 | 下载 | | 020192 | 005 | AP | Review | 2008/02/19 | 下载 | | 020192 | 003 | AP | Review | 2011/02/04 | 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 | | 020192 | 014 | AP | 1998/09/03 | Control Supplement | | 020192 | 013 | AP | 1997/06/30 | Control Supplement | | 020192 | 012 | AP | 1997/04/03 | Control Supplement | | 020192 | 011 | AP | 1997/01/21 | Control Supplement | | 020192 | 010 | AP | 1996/10/04 | Manufacturing Change or Addition | | 020192 | 009 | AP | 1996/12/06 | Control Supplement | | 020192 | 007 | AP | 1996/08/08 | Control Supplement | | 020192 | 006 | AP | 1995/11/02 | Manufacturing Change or Addition | | 020192 | 005 | AP | 1995/10/17 | Control Supplement | | 020192 | 004 | AP | 1995/04/25 | Control Supplement | | 020192 | 003 | AP | 1997/01/21 | New or Modified Indication | | 020192 | 002 | AP | 1993/08/04 | Manufacturing Change or Addition | | 020192 | 000 | AP | 1992/12/30 | Approval |
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