| 药品名称 | FORTAZ | | 申请号 | 050578 | 产品号 | 001 | | 活性成分 | CEFTAZIDIME | 市场状态 | 处方药 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 500MG/VIAL | | 治疗等效代码 | AP | 参比药物 | 是 | | 批准日期 | 1985/07/19 | 申请机构 | IGI LABORATORIES 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 | | 050578 | 055 | AP | Letter | 2014/09/26 | 下载 | | 050578 | 055 | AP | Label | 2014/09/26 | 下载 | | 050578 | 053 | AP | Label | 2007/07/10 | 下载 | | 050578 | 053 | AP | Letter | 2007/07/16 | 下载 | | 050578 | 051 | AP | Label | 2007/03/15 | 下载 | | 050578 | 046 | AP | Letter | 2004/05/26 | 下载 | | 050578 | 046 | AP | Label | 2004/05/27 | 下载 | | 050578 | 042 | AP | Letter | 2002/03/22 | 下载 | | 050578 | 040 | AP | Letter | 2002/03/29 | 下载 | | 050578 | 040 | AP | Label | 2002/03/29 | 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 | | 050578 | 060 | AP | 2015/03/03 | Manufacturing Change or Addition | | 050578 | 055 | AP | 2014/09/24 | Labeling Revision | | 050578 | 053 | AP | 2007/07/09 | Labeling Revision | | 050578 | 051 | AP | 2007/03/14 | Labeling Revision | | 050578 | 046 | AP | 2004/05/19 | Labeling Revision | | 050578 | 044 | AP | 2002/10/23 | Control Supplement | | 050578 | 043 | AP | 2002/02/22 | Control Supplement | | 050578 | 042 | AP | 2002/03/22 | Labeling Revision | | 050578 | 040 | AP | 2002/03/29 | Labeling Revision | | 050578 | 039 | AP | 1997/11/25 | Control Supplement | | 050578 | 038 | AP | 1997/04/03 | Manufacturing Change or Addition | | 050578 | 037 | AP | 1996/12/24 | Labeling Revision | | 050578 | 036 | AP | 1996/10/04 | Control Supplement | | 050578 | 035 | AP | 1995/11/03 | Manufacturing Change or Addition | | 050578 | 034 | AP | 1996/06/20 | Labeling Revision | | 050578 | 033 | AP | 1996/06/20 | Labeling Revision | | 050578 | 032 | AP | 1998/01/26 | Labeling Revision | | 050578 | 031 | AP | 1996/08/20 | Labeling Revision | | 050578 | 030 | AP | 1996/09/11 | Labeling Revision | | 050578 | 029 | AP | 1993/02/18 | Manufacturing Change or Addition | | 050578 | 028 | AP | 1992/12/31 | Labeling Revision | | 050578 | 027 | AP | 1994/10/20 | Labeling Revision | | 050578 | 026 | AP | 1991/08/09 | Manufacturing Change or Addition | | 050578 | 024 | AP | 1992/02/13 | Package Change | | 050578 | 022 | AP | 1994/09/07 | Labeling Revision | | 050578 | 021 | AP | 1992/02/13 | Control Supplement | | 050578 | 020 | AP | 1990/03/22 | Manufacturing Change or Addition | | 050578 | 018 | AP | 1990/04/10 | Chemistry Generic | | 050578 | 017 | AP | 1993/04/29 | Labeling Revision | | 050578 | 015 | AP | 1993/04/29 | Labeling Revision | | 050578 | 000 | AP | 1985/07/19 | Approval |
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