药品名称 | NORCURON | 申请号 | 018776 | 产品号 | 002 | 活性成分 | VECURONIUM BROMIDE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1984/04/30 | 申请机构 | ORGANON USA INC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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与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
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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 | 018776 | 030 | AP | Letter | 2010/11/29 | 下载 | 018776 | 027 | AP | Letter | 2003/06/08 | 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 | 018776 | 030 | AP | 2010/11/22 | Labeling Revision | 018776 | 027 | AP | 2003/05/19 | Labeling Revision | 018776 | 026 | AP | 2001/02/02 | Control Supplement | 018776 | 025 | AP | 2000/04/11 | Control Supplement | 018776 | 024 | AP | 1999/03/15 | Manufacturing Change or Addition | 018776 | 023 | AP | 2000/08/24 | Labeling Revision | 018776 | 022 | AP | 1997/06/19 | Control Supplement | 018776 | 021 | AP | 1994/02/28 | Manufacturing Change or Addition | 018776 | 020 | AP | 1994/05/10 | Control Supplement | 018776 | 019 | AP | 1990/10/05 | Manufacturing Change or Addition | 018776 | 017 | AP | 1989/07/14 | Manufacturing Change or Addition | 018776 | 016 | AP | 1992/01/03 | Labeling Revision | 018776 | 015 | AP | 1992/01/03 | Package Change | 018776 | 011 | AP | 1988/02/08 | Labeling Revision | 018776 | 010 | AP | 1988/02/08 | Control Supplement | 018776 | 009 | AP | 1987/01/28 | Labeling Revision | 018776 | 008 | AP | 1987/01/28 | Control Supplement | 018776 | 007 | AP | 1987/12/29 | New Dosage Regimen | 018776 | 006 | AP | 1986/05/12 | Labeling Revision | 018776 | 005 | AP | 1986/05/12 | Control Supplement | 018776 | 004 | AP | 1987/01/28 | Labeling Revision | 018776 | 003 | AP | 1987/01/28 | Control Supplement | 018776 | 002 | AP | 1984/12/17 | Labeling Revision | 018776 | 001 | AP | 1984/12/17 | Manufacturing Change or Addition | 018776 | 000 | AP | 1984/04/30 | Approval |
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