| 药品名称 | COSOPT | | 申请号 | 020869 | 产品号 | 001 | | 活性成分 | DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | EQ 2% BASE;EQ 0.5% BASE | | 治疗等效代码 | AT | 参比药物 | 是 | | 批准日期 | 1998/04/07 | 申请机构 | OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
| | 化学类型 | New combination | 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 | | 020869 | 040 | AP | Letter | 2015/08/03 | 下载 | | 020869 | 040 | AP | Label | 2015/08/04 | 下载 | | 020869 | 036 | AP | Letter | 2010/06/22 | 下载 | | 020869 | 036 | AP | Label | 2010/06/24 | 下载 | | 020869 | 034 | AP | Letter | 2008/10/23 | 下载 | | 020869 | 034 | AP | Label | 2008/11/07 | 下载 | | 020869 | 030 | AP | Label | 2006/08/11 | 下载 | | 020869 | 030 | AP | Letter | 2006/08/14 | 下载 | | 020869 | 028 | AP | Letter | 2006/05/01 | 下载 | | 020869 | 028 | AP | Label | 2006/05/01 | 下载 | | 020869 | 026 | AP | Letter | 2006/05/01 | 下载 | | 020869 | 026 | AP | Label | 2006/05/01 | 下载 | | 020869 | 022 | AP | Label | 2005/12/15 | 下载 | | 020869 | 022 | AP | Letter | 2005/12/15 | 下载 | | 020869 | 020 | AP | Letter | 2005/03/30 | 下载 | | 020869 | 020 | AP | Label | 2005/03/30 | 下载 | | 020869 | 012 | AP | Letter | 2002/04/23 | 下载 | | 020869 | 012 | AP | Label | 2002/04/23 | 下载 | | 020869 | 001 | AP | Review | 1999/01/04 | 下载 | | 020869 | 000 | AP | Review | 2003/08/08 | 下载 | | 020869 | 000 | AP | Letter | 1998/04/07 | 下载 | | 020869 | 000 | AP | Label | 1998/04/07 | 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 | | 020869 | 040 | AP | 2015/07/31 | Labeling Revision | | 020869 | 036 | AP | 2010/06/18 | Labeling Revision | | 020869 | 034 | AP | 2008/10/22 | Labeling Revision | | 020869 | 030 | AP | 2006/08/09 | Labeling Revision | | 020869 | 028 | AP | 2006/04/26 | Labeling Revision | | 020869 | 026 | AP | 2006/04/26 | Labeling Revision | | 020869 | 022 | AP | 2005/12/09 | Labeling Revision | | 020869 | 020 | AP | 2005/03/28 | Labeling Revision | | 020869 | 015 | AP | 2002/12/06 | Package Change | | 020869 | 013 | AP | 2002/05/16 | Manufacturing Change or Addition | | 020869 | 012 | AP | 2002/04/23 | Labeling Revision | | 020869 | 011 | AP | 2002/08/28 | Control Supplement | | 020869 | 010 | AP | 2001/12/04 | Manufacturing Change or Addition | | 020869 | 009 | AP | 2001/12/04 | Manufacturing Change or Addition | | 020869 | 008 | AP | 2001/07/24 | Manufacturing Change or Addition | | 020869 | 007 | AP | 2001/07/19 | Control Supplement | | 020869 | 006 | AP | 2000/08/24 | Labeling Revision | | 020869 | 005 | AP | 2000/11/21 | Manufacturing Change or Addition | | 020869 | 003 | AP | 2000/01/23 | Labeling Revision | | 020869 | 002 | AP | 2000/11/09 | Control Supplement | | 020869 | 001 | AP | 1999/01/04 | Labeling Revision | | 020869 | 000 | AP | 1998/04/07 | Approval |
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