| 药品名称 | ASTEPRO | | 申请号 | 022203 | 产品号 | 001 | | 活性成分 | AZELASTINE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | SPRAY, METERED;NASAL | 规格 | EQ 0.125MG BASE/SPRAY | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2008/10/15 | 申请机构 | MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
| | 化学类型 | New formulation or new manufacturer | 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 | | NPP | 2016/08/30 | | M-129 | 2016/08/30 | | NPP | 2018/02/20 | | NPP | 2018/02/20 | | 历史市场独占权保护信息 | | NP | 2011/10/15 |
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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 | | 022203 | 011 | AP | Label | 2015/02/23 | 下载 | | 022203 | 011 | AP | Letter | 2015/02/24 | 下载 | | 022203 | 010 | AP | Label | 2015/02/23 | 下载 | | 022203 | 010 | AP | Letter | 2015/02/24 | 下载 | | 022203 | 008 | AP | Letter | 2013/09/04 | 下载 | | 022203 | 008 | AP | Label | 2013/09/09 | 下载 | | 022203 | 006 | AP | Label | 2011/01/25 | 下载 | | 022203 | 006 | AP | Letter | 2011/01/25 | 下载 | | 022203 | 003 | AP | Label | 2009/11/06 | 下载 | | 022203 | 003 | AP | Letter | 2009/11/24 | 下载 | | 022203 | 000 | AP | Letter | 2008/10/22 | 下载 | | 022203 | 000 | AP | Review | 2009/08/14 | 下载 | | 022203 | 000 | AP | Summary Review | 2009/08/14 | 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 | | 022203 | 014 | AP | 2015/09/25 | Manufacturing Change or Addition | | 022203 | 011 | AP | 2015/02/20 | Efficacy Supplement with Clinical Data to Support | | 022203 | 010 | AP | 2015/02/20 | Efficacy Supplement with Clinical Data to Support | | 022203 | 009 | AP | 2014/03/13 | Manufacturing Change or Addition | | 022203 | 008 | AP | 2013/08/30 | Efficacy Supplement with Clinical Data to Support | | 022203 | 006 | AP | 2011/01/19 | Labeling Revision | | 022203 | 003 | AP | 2009/08/31 | Labeling Revision | | 022203 | 000 | AP | 2008/10/15 | Approval |
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