| 药品名称 | ZYPREXA | | 申请号 | 021253 | 产品号 | 001 | | 活性成分 | OLANZAPINE | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INTRAMUSCULAR | 规格 | 10MG/VIAL | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 2004/03/29 | 申请机构 | ELI LILLY AND CO
| | 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 | | NDF | 2007/03/29 | | NP | 2007/03/29 | | PED | 2007/09/29 |
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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 | | 021253 | 056 | AP | Letter | 2016/10/14 | 下载 | | 021253 | 049 | AP | Label | 2015/07/24 | 下载 | | 021253 | 048 | AP | Letter | 2014/12/23 | 下载 | | 021253 | 048 | AP | Label | 2015/01/09 | 下载 | | 021253 | 045 | AP | Label | 2010/12/04 | 下载 | | 021253 | 045 | AP | Letter | 2010/12/06 | 下载 | | 021253 | 043 | AP | Medication Guide | 2010/06/03 | 下载 | | 021253 | 043 | AP | Letter | 2010/06/03 | 下载 | | 021253 | 043 | AP | Label | 2010/06/03 | 下载 | | 021253 | 039 | AP | Medication Guide | 2010/06/03 | 下载 | | 021253 | 039 | AP | Label | 2010/06/03 | 下载 | | 021253 | 039 | AP | Letter | 2010/06/03 | 下载 | | 021253 | 037 | AP | Label | 2010/01/29 | 下载 | | 021253 | 037 | AP | Letter | 2010/02/01 | 下载 | | 021253 | 036 | AP | Label | 2009/09/17 | 下载 | | 021253 | 036 | AP | Letter | 2009/11/19 | 下载 | | 021253 | 033 | AP | Letter | 2008/08/19 | 下载 | | 021253 | 026 | AP | Letter | 2007/07/10 | 下载 | | 021253 | 026 | AP | Label | 2007/07/10 | 下载 | | 021253 | 021 | AP | Label | 2006/12/04 | 下载 | | 021253 | 021 | AP | Letter | 2006/12/28 | 下载 | | 021253 | 016 | AP | Label | 2006/02/28 | 下载 | | 021253 | 016 | AP | Letter | 2006/03/01 | 下载 | | 021253 | 015 | AP | Letter | 2005/09/15 | 下载 | | 021253 | 012 | AP | Label | 2006/02/22 | 下载 | | 021253 | 012 | AP | Letter | 2006/02/22 | 下载 | | 021253 | 006 | AP | Label | 2006/08/29 | 下载 | | 021253 | 006 | AP | Letter | 2006/09/18 | 下载 | | 021253 | 004 | AP | Label | 2006/02/22 | 下载 | | 021253 | 004 | AP | Letter | 2006/02/22 | 下载 | | 021253 | 000 | AP | Label | 2004/04/05 | 下载 | | 021253 | 000 | AP | Letter | 2004/04/07 | 下载 | | 021253 | 000 | AP | Review | 2005/07/13 | 下载 | | 021253 | 000 | AP | Other Important Information from FDA | 2011/12/22 | 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 | | 021253 | 056 | AP | 2016/10/06 | Labeling Revision | | 021253 | 054 | AP | 2016/10/13 | Manufacturing Change or Addition | | 021253 | 052 | AP | 2014/08/11 | Manufacturing Change or Addition | | 021253 | 049 | AP | 2015/07/23 | Labeling Revision | | 021253 | 048 | AP | 2014/12/19 | Labeling Revision | | 021253 | 045 | AP | 2010/12/01 | Labeling Revision | | 021253 | 044 | AP | 2014/09/30 | Manufacturing Change or Addition | | 021253 | 043 | AP | 2010/05/27 | Labeling Revision | | 021253 | 039 | AP | 2010/05/27 | Labeling Revision | | 021253 | 037 | AP | 2010/01/27 | Labeling Revision | | 021253 | 036 | AP | 2009/08/31 | Labeling Revision | | 021253 | 033 | AP | 2008/08/14 | Labeling Revision | | 021253 | 026 | AP | 2007/07/06 | Labeling Revision | | 021253 | 021 | AP | 2006/11/29 | Labeling Revision | | 021253 | 016 | AP | 2006/02/23 | Labeling Revision | | 021253 | 015 | AP | 2005/09/13 | Labeling Revision | | 021253 | 012 | AP | 2006/02/16 | Labeling Revision | | 021253 | 006 | AP | 2006/08/25 | Labeling Revision | | 021253 | 004 | AP | 2006/02/16 | Labeling Revision | | 021253 | 000 | AP | 2004/03/29 | Approval |
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