药品名称 | TYGACIL | 申请号 | 021821 | 产品号 | 001 | 活性成分 | TIGECYCLINE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;IV (INFUSION) | 规格 | 50MG/VIAL | 治疗等效代码 | AP | 参比药物 | 是 | 批准日期 | 2005/06/15 | 申请机构 | PF PRISM CV
| 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 | NCE | 2010/06/15 |
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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 | 021821 | 043 | AP | Letter | 2016/01/21 | 下载 | 021821 | 043 | AP | Label | 2016/01/26 | 下载 | 021821 | 042 | AP | Letter | 2016/06/30 | 下载 | 021821 | 042 | AP | Label | 2016/07/14 | 下载 | 021821 | 039 | AP | Letter | 2016/06/01 | 下载 | 021821 | 039 | AP | Label | 2016/06/01 | 下载 | 021821 | 037 | AP | Label | 2013/05/24 | 下载 | 021821 | 037 | AP | Letter | 2013/05/28 | 下载 | 021821 | 031 | AP | Label | 2013/09/27 | 下载 | 021821 | 031 | AP | Letter | 2013/10/01 | 下载 | 021821 | 031 | AP | Review | 2014/01/16 | 下载 | 021821 | 027 | AP | Letter | 2010/07/23 | 下载 | 021821 | 027 | AP | Label | 2010/07/19 | 下载 | 021821 | 026 | AP | Label | 2013/09/27 | 下载 | 021821 | 026 | AP | Review | 2014/01/16 | 下载 | 021821 | 026 | AP | Letter | 2013/10/01 | 下载 | 021821 | 025 | AP | Letter | 2010/07/23 | 下载 | 021821 | 025 | AP | Label | 2010/07/16 | 下载 | 021821 | 022 | AP | Letter | 2009/06/30 | 下载 | 021821 | 021 | AP | Label | 2010/07/19 | 下载 | 021821 | 021 | AP | Letter | 2010/07/23 | 下载 | 021821 | 019 | AP | Letter | 2009/02/03 | 下载 | 021821 | 019 | AP | Label | 2009/02/04 | 下载 | 021821 | 018 | AP | Letter | 2009/03/25 | 下载 | 021821 | 018 | AP | Label | 2009/03/25 | 下载 | 021821 | 017 | AP | Label | 2009/03/25 | 下载 | 021821 | 017 | AP | Letter | 2009/03/25 | 下载 | 021821 | 016 | AP | Label | 2009/02/10 | 下载 | 021821 | 016 | AP | Letter | 2009/02/13 | 下载 | 021821 | 014 | AP | Label | 2009/02/04 | 下载 | 021821 | 014 | AP | Letter | 2009/02/03 | 下载 | 021821 | 013 | AP | Label | 2009/03/25 | 下载 | 021821 | 013 | AP | Letter | 2009/03/25 | 下载 | 021821 | 011 | AP | Letter | 2009/02/03 | 下载 | 021821 | 010 | AP | Letter | 2007/05/29 | 下载 | 021821 | 010 | AP | Label | 2007/05/29 | 下载 | 021821 | 007 | AP | Label | 2007/04/06 | 下载 | 021821 | 007 | AP | Letter | 2007/04/09 | 下载 | 021821 | 006 | AP | Letter | 2007/02/02 | 下载 | 021821 | 004 | AP | Letter | 2006/07/21 | 下载 | 021821 | 003 | AP | Letter | 2006/07/21 | 下载 | 021821 | 000 | AP | Label | 2005/06/17 | 下载 | 021821 | 000 | AP | Letter | 2005/06/21 | 下载 | 021821 | 000 | AP | Review | 2005/08/24 | 下载 | 021821 | 000 | AP | Other Important Information from FDA | 2011/12/21 | 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 | 021821 | 044 | AP | 2016/09/07 | Manufacturing Change or Addition | 021821 | 043 | AP | 2016/01/19 | Labeling Revision | 021821 | 042 | AP | 2016/06/29 | Labeling Revision | 021821 | 039 | AP | 2016/05/31 | Labeling Revision | 021821 | 037 | AP | 2013/05/23 | Labeling Revision | 021821 | 036 | AP | 2014/01/09 | Manufacturing Change or Addition | 021821 | 031 | AP | 2013/09/26 | Labeling Revision | 021821 | 027 | AP | 2010/07/16 | Labeling Revision | 021821 | 026 | AP | 2013/09/26 | Labeling Revision | 021821 | 025 | AP | 2010/07/16 | Labeling Revision | 021821 | 022 | AP | 2009/06/26 | Package Change | 021821 | 021 | AP | 2010/07/16 | Labeling Revision | 021821 | 019 | AP | 2009/01/29 | Labeling Revision | 021821 | 018 | AP | 2009/03/20 | New or Modified Indication | 021821 | 017 | AP | 2009/03/20 | New or Modified Indication | 021821 | 016 | AP | 2009/02/10 | Labeling Revision | 021821 | 014 | AP | 2009/01/29 | Labeling Revision | 021821 | 013 | AP | 2009/03/20 | New or Modified Indication | 021821 | 011 | AP | 2009/01/29 | Labeling Revision | 021821 | 010 | AP | 2007/05/18 | Labeling Revision | 021821 | 007 | AP | 2007/04/02 | Labeling Revision | 021821 | 006 | AP | 2007/01/24 | Labeling Revision | 021821 | 004 | AP | 2006/07/12 | Formulation Revision | 021821 | 003 | AP | 2006/07/12 | Labeling Revision | 021821 | 000 | AP | 2005/06/15 | Approval |
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