| 药品名称 | ZEMURON | | 申请号 | 020214 | 产品号 | 001 | | 活性成分 | ROCURONIUM BROMIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1994/03/17 | 申请机构 | ORGANON USA INC
| | 化学类型 | New molecular entity (NME) | 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 | | NPP | 2011/08/28 | | PED | 2012/02/28 |
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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 | | 020214 | 036 | AP | Letter | 2015/01/08 | 下载 | | 020214 | 036 | AP | Label | 2015/01/08 | 下载 | | 020214 | 034 | AP | Label | 2010/11/22 | 下载 | | 020214 | 034 | AP | Letter | 2010/11/30 | 下载 | | 020214 | 030 | AP | Label | 2008/08/29 | 下载 | | 020214 | 030 | AP | Letter | 2008/08/29 | 下载 | | 020214 | 021 | AP | Letter | 2004/08/25 | 下载 | | 020214 | 017 | AP | Letter | 2003/06/08 | 下载 | | 020214 | 016 | AP | Letter | 2004/03/03 | 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 | | 020214 | 036 | AP | 2015/01/06 | Labeling Revision | | 020214 | 035 | AP | 2013/04/29 | Manufacturing Change or Addition | | 020214 | 034 | AP | 2010/11/22 | Labeling Revision | | 020214 | 030 | AP | 2008/08/28 | Patient Population Altered | | 020214 | 021 | AP | 2004/08/18 | Labeling Revision | | 020214 | 017 | AP | 2003/06/04 | Labeling Revision | | 020214 | 016 | AP | 2004/02/06 | Labeling Revision | | 020214 | 015 | AP | 2001/07/20 | Control Supplement | | 020214 | 013 | AP | 2001/06/05 | Labeling Revision | | 020214 | 010 | AP | 2000/03/27 | Labeling Revision | | 020214 | 009 | AP | 1999/03/17 | Manufacturing Change or Addition | | 020214 | 008 | AP | 2000/03/27 | Labeling Revision | | 020214 | 007 | AP | 1997/06/30 | Control Supplement | | 020214 | 006 | AP | 1997/12/03 | Control Supplement | | 020214 | 005 | AP | 1996/07/25 | Control Supplement | | 020214 | 004 | AP | 1996/06/21 | Package Change | | 020214 | 003 | AP | 1994/12/07 | Labeling Revision | | 020214 | 002 | AP | 1995/10/04 | Control Supplement | | 020214 | 001 | AP | 1994/11/22 | Control Supplement | | 020214 | 000 | AP | 1994/03/17 | Approval |
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