| 药品名称 | ALPHAGAN P | | 申请号 | 021262 | 产品号 | 001 | | 活性成分 | BRIMONIDINE TARTRATE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | 0.15% | | 治疗等效代码 | AT | 参比药物 | 是 | | 批准日期 | 2001/03/16 | 申请机构 | ALLERGAN INC
| | 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 | | 021262 | 020 | AP | Letter | 2010/08/16 | 下载 | | 021262 | 020 | AP | Label | 2010/08/28 | 下载 | | 021262 | 018 | AP | Label | 2006/05/24 | 下载 | | 021262 | 018 | AP | Letter | 2006/05/25 | 下载 | | 021262 | 013 | AP | Letter | 2004/02/27 | 下载 | | 021262 | 010 | AP | Letter | 2004/02/27 | 下载 | | 021262 | 006 | AP | Review | 2004/05/27 | 下载 | | 021262 | 006 | AP | Letter | 2001/12/20 | 下载 | | 021262 | 006 | AP | Label | 2001/12/20 | 下载 | | 021262 | 000 | AP | Letter | 2001/03/16 | 下载 | | 021262 | 000 | AP | Label | 2001/03/16 | 下载 | | 021262 | 000 | AP | Review | 2004/05/27 | 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 | | 021262 | 024 | AP | 2014/05/19 | Manufacturing Change or Addition | | 021262 | 020 | AP | 2010/08/13 | Labeling Revision | | 021262 | 018 | AP | 2006/05/22 | Labeling Revision | | 021262 | 013 | AP | 2004/02/10 | Labeling Revision | | 021262 | 010 | AP | 2004/02/10 | Package Change | | 021262 | 009 | AP | 2002/04/12 | Manufacturing Change or Addition | | 021262 | 008 | AP | 2002/06/19 | Control Supplement | | 021262 | 007 | AP | 2002/01/22 | Manufacturing Change or Addition | | 021262 | 006 | AP | 2001/12/20 | Patient Population Altered | | 021262 | 005 | AP | 2001/12/04 | Manufacturing Change or Addition | | 021262 | 004 | AP | 2001/12/18 | Control Supplement | | 021262 | 003 | AP | 2001/10/15 | Control Supplement | | 021262 | 002 | AP | 2001/06/05 | Manufacturing Change or Addition | | 021262 | 001 | AP | 2001/10/23 | Manufacturing Change or Addition | | 021262 | 000 | AP | 2001/03/16 | Approval |
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