| 药品名称 | ZOVIRAX | | 申请号 | 018603 | 产品号 | 001 | | 活性成分 | ACYCLOVIR SODIUM | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1982/10/22 | 申请机构 | GLAXOSMITHKLINE
| | 化学类型 | | 审评分类 | Priority 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 | | 018603 | 027 | AP | Letter | 2004/05/27 | 下载 | | 018603 | 027 | AP | Label | 2004/05/27 | 下载 | | 018603 | 025 | AP | Letter | 2002/01/29 | 下载 | | 018603 | 024 | AP | Letter | 2002/01/29 | 下载 | | 018603 | 023 | AP | Letter | 2002/01/29 | 下载 | | 018603 | 019 | AP | Letter | 1998/06/02 | 下载 | | 018603 | 019 | AP | Label | 1998/06/02 | 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 | | 018603 | 027 | AP | 2004/05/19 | Labeling Revision | | 018603 | 025 | AP | 2002/01/29 | Labeling Revision | | 018603 | 024 | AP | 2002/01/29 | Labeling Revision | | 018603 | 023 | AP | 2002/01/29 | Labeling Revision | | 018603 | 022 | AP | 2000/07/12 | Manufacturing Change or Addition | | 018603 | 021 | AP | 1999/07/15 | Control Supplement | | 018603 | 020 | AP | 1999/05/19 | Labeling Revision | | 018603 | 019 | AP | 1998/06/02 | New or Modified Indication | | 018603 | 018 | AP | 1996/10/29 | Control Supplement | | 018603 | 017 | AP | 1995/06/07 | Manufacturing Change or Addition | | 018603 | 015 | AP | 1994/04/14 | Labeling Revision | | 018603 | 014 | AP | 1993/11/09 | Control Supplement | | 018603 | 013 | AP | 1993/04/22 | Labeling Revision | | 018603 | 012 | AP | 1992/07/17 | Control Supplement | | 018603 | 011 | AP | 1989/06/29 | Package Change | | 018603 | 010 | AP | 1993/04/22 | Labeling Revision | | 018603 | 009 | AP | 1990/02/09 | New or Modified Indication | | 018603 | 008 | AP | 1984/07/09 | Labeling Revision | | 018603 | 007 | AP | 1984/05/31 | Manufacturing Change or Addition | | 018603 | 006 | AP | 1984/08/14 | Expiration Date Change | | 018603 | 005 | AP | 1984/05/08 | Manufacturing Change or Addition | | 018603 | 004 | AP | 1983/08/30 | Manufacturing Change or Addition | | 018603 | 003 | AP | 1990/02/09 | New or Modified Indication | | 018603 | 002 | AP | 1983/01/05 | Expiration Date Change | | 018603 | 001 | AP | 1982/12/14 | Control Supplement | | 018603 | 000 | AP | 1982/10/22 | Approval |
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