| 药品名称 | TRUSOPT | | 申请号 | 020408 | 产品号 | 001 | | 活性成分 | DORZOLAMIDE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | SOLUTION/DROPS;OPHTHALMIC | 规格 | EQ 2% BASE | | 治疗等效代码 | AT | 参比药物 | 是 | | 批准日期 | 1994/12/09 | 申请机构 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Priority 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 | | M-38 | 2007/04/15 | | PED | 2007/10/15 |
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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 | | 020408 | 050 | AP | Label | 2014/02/06 | 下载 | | 020408 | 050 | AP | Letter | 2014/02/10 | 下载 | | 020408 | 047 | AP | Letter | 2010/06/22 | 下载 | | 020408 | 047 | AP | Label | 2010/06/24 | 下载 | | 020408 | 045 | AP | Letter | 2008/10/24 | 下载 | | 020408 | 045 | AP | Label | 2008/11/07 | 下载 | | 020408 | 039 | AP | Label | 2006/01/05 | 下载 | | 020408 | 039 | AP | Letter | 2006/01/19 | 下载 | | 020408 | 033 | AP | Review | 2008/07/31 | 下载 | | 020408 | 033 | AP | Letter | 2004/04/20 | 下载 | | 020408 | 033 | AP | Label | 2004/05/03 | 下载 | | 020408 | 025 | AP | Letter | 2002/04/09 | 下载 | | 020408 | 025 | AP | Label | 2002/04/09 | 下载 | | 020408 | 023 | AP | Letter | 2002/04/12 | 下载 | | 020408 | 023 | AP | Label | 2002/04/12 | 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 | | 020408 | 050 | AP | 2014/02/03 | Labeling Revision | | 020408 | 047 | AP | 2010/06/18 | Labeling Revision | | 020408 | 045 | AP | 2008/10/22 | Labeling Revision | | 020408 | 039 | AP | 2005/12/16 | Labeling Revision | | 020408 | 033 | AP | 2004/04/15 | Patient Population Altered | | 020408 | 028 | AP | 2002/12/06 | Package Change | | 020408 | 026 | AP | 2002/04/19 | Manufacturing Change or Addition | | 020408 | 025 | AP | 2002/05/15 | Labeling Revision | | 020408 | 024 | AP | 2002/04/15 | Manufacturing Change or Addition | | 020408 | 023 | AP | 2002/05/15 | Labeling Revision | | 020408 | 022 | AP | 2001/12/04 | Manufacturing Change or Addition | | 020408 | 021 | AP | 2000/09/18 | Labeling Revision | | 020408 | 020 | AP | 2001/01/18 | Manufacturing Change or Addition | | 020408 | 019 | AP | 2000/02/15 | Labeling Revision | | 020408 | 017 | AP | 1999/09/27 | Labeling Revision | | 020408 | 016 | AP | 1999/06/06 | Labeling Revision | | 020408 | 015 | AP | 1998/12/01 | Labeling Revision | | 020408 | 014 | AP | 1998/10/19 | Control Supplement | | 020408 | 013 | AP | 1998/08/03 | Labeling Revision | | 020408 | 012 | AP | 1997/12/12 | Control Supplement | | 020408 | 011 | AP | 1998/08/03 | Labeling Revision | | 020408 | 010 | AP | 1998/08/03 | Labeling Revision | | 020408 | 009 | AP | 1997/06/13 | Control Supplement | | 020408 | 008 | AP | 1997/02/20 | Control Supplement | | 020408 | 007 | AP | 1998/08/03 | Labeling Revision | | 020408 | 006 | AP | 1998/08/03 | Labeling Revision | | 020408 | 005 | AP | 1996/07/22 | Control Supplement | | 020408 | 004 | AP | 1995/10/31 | Manufacturing Change or Addition | | 020408 | 003 | AP | 1995/10/31 | Control Supplement | | 020408 | 002 | AP | 1995/03/23 | Formulation Revision | | 020408 | 001 | AP | 1995/04/25 | Package Change | | 020408 | 000 | AP | 1994/12/09 | Approval |
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