| 药品名称 | PHOTOFRIN | | 申请号 | 020451 | 产品号 | 001 | | 活性成分 | PORFIMER SODIUM | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 75MG/VIAL | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1995/12/27 | 申请机构 | CONCORDIA LABORATORIES INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | I-391 | 2006/08/01 | | ODE | 2010/08/01 |
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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 | | 020451 | 023 | AP | Label | 2011/06/28 | 下载 | | 020451 | 023 | AP | Letter | 2011/07/05 | 下载 | | 020451 | 020 | AP | Label | 2011/04/04 | 下载 | | 020451 | 020 | AP | Letter | 2011/04/06 | 下载 | | 020451 | 019 | AP | Label | 2008/09/09 | 下载 | | 020451 | 019 | AP | Letter | 2008/09/09 | 下载 | | 020451 | 016 | AP | Letter | 2005/10/20 | 下载 | | 020451 | 012 | AP | Review | 2006/07/25 | 下载 | | 020451 | 012 | AP | Label | 2003/08/14 | 下载 | | 020451 | 012 | AP | Letter | 2003/08/15 | 下载 | | 020451 | 003 | AP | Letter | 1998/12/22 | 下载 | | 020451 | 002 | AP | Letter | 1998/01/09 | 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 | | 020451 | 023 | AP | 2011/06/24 | Labeling Revision | | 020451 | 020 | AP | 2011/04/04 | Labeling Revision | | 020451 | 019 | AP | 2008/09/08 | Efficacy Supplement with Clinical Data to Support | | 020451 | 016 | AP | 2005/10/29 | Labeling Revision | | 020451 | 013 | AP | 2002/07/19 | Manufacturing Change or Addition | | 020451 | 012 | AP | 2003/08/01 | Supplement | | 020451 | 010 | AP | 2001/09/25 | Manufacturing Change or Addition | | 020451 | 009 | AP | 2001/05/08 | Manufacturing Change or Addition | | 020451 | 008 | AP | 2001/06/15 | Manufacturing Change or Addition | | 020451 | 006 | AP | 2000/07/06 | Labeling Revision | | 020451 | 005 | AP | 1999/03/17 | Control Supplement | | 020451 | 003 | AP | 1998/12/22 | New or Modified Indication | | 020451 | 002 | AP | 1998/01/09 | New or Modified Indication | | 020451 | 001 | AP | 1996/09/10 | Manufacturing Change or Addition | | 020451 | 000 | AP | 1995/12/27 | Approval |
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