| 药品名称 | NICODERM CQ | | 申请号 | 020165 | 产品号 | 004 | | 活性成分 | NICOTINE | 市场状态 | 非处方药 | | 剂型或给药途径 | FILM, EXTENDED RELEASE;TRANSDERMAL | 规格 | 21MG/24HR | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 1996/08/02 | 申请机构 | SANOFI AVENTIS US LLC
| | 化学类型 | New dosage form | 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 | | 020165 | 038 | AP | Letter | 2016/05/06 | 下载 | | 020165 | 038 | AP | Label | 2016/05/06 | 下载 | | 020165 | 036 | AP | Letter | 2015/10/13 | 下载 | | 020165 | 036 | AP | Label | 2015/11/25 | 下载 | | 020165 | 035 | AP | Letter | 2015/08/10 | 下载 | | 020165 | 035 | AP | Label | 2015/08/10 | 下载 | | 020165 | 034 | AP | Letter | 2015/02/05 | 下载 | | 020165 | 034 | AP | Label | 2015/02/17 | 下载 | | 020165 | 031 | AP | Letter | 2013/11/06 | 下载 | | 020165 | 031 | AP | Label | 2013/11/19 | 下载 | | 020165 | 029 | AP | Letter | 2014/05/01 | 下载 | | 020165 | 029 | AP | Label | 2014/05/06 | 下载 | | 020165 | 028 | AP | Letter | 2012/09/24 | 下载 | | 020165 | 024 | AP | Label | 2007/04/19 | 下载 | | 020165 | 024 | AP | Letter | 2007/04/20 | 下载 | | 020165 | 023 | AP | Label | 2006/09/18 | 下载 | | 020165 | 023 | AP | Letter | 2006/09/20 | 下载 | | 020165 | 020 | AP | Review | 2007/11/19 | 下载 | | 020165 | 020 | AP | Letter | 2002/08/13 | 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 | | 020165 | 038 | AP | 2016/05/04 | Labeling Revision | | 020165 | 037 | AP | 2015/10/26 | Manufacturing Change or Addition | | 020165 | 036 | AP | 2015/10/07 | Labeling Revision | | 020165 | 035 | AP | 2015/08/06 | Labeling Revision | | 020165 | 034 | AP | 2015/02/03 | Labeling Revision | | 020165 | 031 | AP | 2013/10/31 | Labeling Revision | | 020165 | 029 | AP | 2014/04/30 | Labeling Revision | | 020165 | 028 | AP | 2012/09/20 | Labeling Revision | | 020165 | 026 | AP | 2014/02/20 | Manufacturing Change or Addition | | 020165 | 024 | AP | 2007/04/13 | Labeling Revision | | 020165 | 023 | AP | 2006/09/15 | Labeling Revision | | 020165 | 020 | AP | 2002/08/13 | Labeling Revision | | 020165 | 019 | AP | 2001/06/08 | Labeling Revision | | 020165 | 018 | AP | 2000/09/21 | Manufacturing Change or Addition | | 020165 | 017 | AP | 2000/02/16 | Formulation Revision | | 020165 | 016 | AP | 2000/02/16 | Labeling Revision | | 020165 | 015 | AP | 1999/09/14 | Control Supplement | | 020165 | 014 | AP | 1997/08/21 | Manufacturing Change or Addition | | 020165 | 013 | AP | 1997/08/21 | Manufacturing Change or Addition | | 020165 | 012 | AP | 1997/09/11 | Package Change | | 020165 | 011 | AP | 1996/08/02 | OTC Labeling | | 020165 | 009 | AP | 1996/01/23 | Package Change | | 020165 | 006 | AP | 1993/07/19 | Control Supplement | | 020165 | 005 | AP | 1993/07/19 | Control Supplement | | 020165 | 004 | AP | 1992/08/12 | Manufacturing Change or Addition | | 020165 | 003 | AP | 1992/07/22 | Manufacturing Change or Addition | | 020165 | 002 | AP | 1992/07/22 | Manufacturing Change or Addition | | 020165 | 000 | AP | 1991/11/07 | Approval |
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