| 药品名称 | ABILIFY MAINTENA KIT | | 申请号 | 202971 | 产品号 | 002 | | 活性成分 | ARIPIPRAZOLE | 市场状态 | 处方药 | | 剂型或给药途径 | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 规格 | 400MG/VIAL | | 治疗等效代码 | | 参比药物 | 是 | | 批准日期 | 2013/02/28 | 申请机构 | OTSUKA PHARMACEUTICAL CO LTD
| | 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 | | NDF | 2016/02/28 | | M-150 | 2017/12/05 | | 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 | | 202971 | 009 | AP | Letter | 2016/08/19 | 下载 | | 202971 | 009 | AP | Label | 2016/08/23 | 下载 | | 202971 | 008 | AP | Letter | 2016/01/20 | 下载 | | 202971 | 008 | AP | Label | 2016/01/22 | 下载 | | 202971 | 006 | AP | Letter | 2015/07/30 | 下载 | | 202971 | 006 | AP | Label | 2015/07/30 | 下载 | | 202971 | 004 | AP | Label | 2014/09/30 | 下载 | | 202971 | 003 | AP | Letter | 2014/12/09 | 下载 | | 202971 | 003 | AP | Label | 2014/12/10 | 下载 | | 202971 | 003 | AP | Review | 2015/07/27 | 下载 | | 202971 | 002 | AP | Label | 2014/06/03 | 下载 | | 202971 | 000 | AP | Letter | 2013/03/01 | 下载 | | 202971 | 000 | AP | Medication Guide | 2013/03/07 | 下载 | | 202971 | 000 | AP | Label | 2013/03/15 | 下载 | | 202971 | 000 | AP | Review | 2013/04/11 | 下载 | | 202971 | 000 | AP | Summary Review | 2013/04/11 | 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 | | 202971 | 009 | AP | 2016/08/18 | Labeling Revision | | 202971 | 008 | AP | 2016/01/15 | Labeling Revision | | 202971 | 007 | AP | 2016/03/24 | Manufacturing Change or Addition | | 202971 | 006 | AP | 2015/07/29 | Efficacy Supplement with Clinical Data to Support | | 202971 | 005 | AP | 2015/01/05 | Manufacturing Change or Addition | | 202971 | 004 | AP | 2014/09/29 | Manufacturing Change or Addition | | 202971 | 003 | AP | 2014/12/05 | Efficacy Supplement with Clinical Data to Support | | 202971 | 002 | AP | 2014/05/30 | Manufacturing Change or Addition | | 202971 | 001 | AP | 2014/08/15 | Manufacturing Change or Addition | | 202971 | 000 | AP | 2013/02/28 | Approval |
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