| 药品名称 | MANDOL | | 申请号 | 050504 | 产品号 | 002 | | 活性成分 | CEFAMANDOLE NAFATE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 1GM BASE/VIAL | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ELI LILLY AND CO
| | 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 | | 050504 | 062 | AP | Letter | 2003/03/10 | 下载 | | 050504 | 059 | AP | Letter | 2002/07/18 | 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 | | 050504 | 064 | AP | 2002/05/22 | Control Supplement | | 050504 | 062 | AP | 2003/03/04 | Labeling Revision | | 050504 | 061 | AP | 1999/01/05 | Manufacturing Change or Addition | | 050504 | 060 | AP | 1996/06/18 | Manufacturing Change or Addition | | 050504 | 059 | AP | 2002/07/18 | Labeling Revision | | 050504 | 058 | AP | 1993/03/23 | Manufacturing Change or Addition | | 050504 | 057 | AP | 1992/12/31 | Labeling Revision | | 050504 | 055 | AP | 1981/11/16 | Labeling Revision | | 050504 | 054 | AP | 1981/09/04 | Labeling Revision | | 050504 | 053 | AP | 1981/02/11 | Control Supplement | | 050504 | 052 | AP | 1980/11/23 | Labeling Revision | | 050504 | 051 | AP | 1980/11/20 | Labeling Revision | | 050504 | 050 | AP | 1980/11/20 | Labeling Revision | | 050504 | 049 | AP | 1980/11/20 | Labeling Revision | | 050504 | 048 | AP | 1980/11/20 | Labeling Revision | | 050504 | 047 | AP | 1980/10/28 | Labeling Revision | | 050504 | 046 | AP | 1980/10/03 | Labeling Revision | | 050504 | 045 | AP | 1980/07/01 | Labeling Revision | | 050504 | 044 | AP | 1980/06/17 | Labeling Revision | | 050504 | 043 | AP | 1980/05/28 | Labeling Revision | | 050504 | 042 | AP | 1980/05/01 | Labeling Revision | | 050504 | 041 | AP | 1980/05/01 | Control Supplement | | 050504 | 040 | AP | 1980/04/14 | Labeling Revision | | 050504 | 039 | AP | 1979/11/13 | Labeling Revision | | 050504 | 038 | AP | 1979/09/10 | Control Supplement | | 050504 | 037 | AP | 1979/08/01 | Labeling Revision | | 050504 | 036 | AP | 1979/05/15 | Labeling Revision | | 050504 | 035 | AP | 1979/08/01 | New or Modified Indication | | 050504 | 034 | AP | 1979/03/21 | Labeling Revision | | 050504 | 033 | AP | 1979/02/06 | Labeling Revision | | 050504 | 032 | AP | 1979/01/15 | Labeling Revision | | 050504 | 031 | AP | 1978/11/21 | Labeling Revision | | 050504 | 030 | AP | 1978/11/15 | Control Supplement | | 050504 | 029 | AP | 1992/10/14 | Labeling Revision | | 050504 | 028 | AP | 1993/06/18 | Labeling Revision | | 050504 | 027 | AP | 1991/06/13 | Labeling Revision | | 050504 | 026 | AP | 1982/09/03 | Labeling Revision | | 050504 | 025 | AP | 1995/05/10 | Labeling Revision | | 050504 | 023 | AP | 1982/07/29 | Labeling Revision | | 050504 | 022 | AP | 1986/03/12 | Labeling Revision | | 050504 | 021 | AP | 1986/03/12 | Labeling Revision | | 050504 | 019 | AP | 1982/07/15 | Labeling Revision | | 050504 | 017 | AP | 1984/09/07 | Package Change | | 050504 | 016 | AP | 1984/02/28 | Control Supplement | | 050504 | 014 | AP | 1983/09/06 | Labeling Revision | | 050504 | 013 | AP | 1983/08/24 | Labeling Revision | | 050504 | 012 | AP | 1983/08/05 | Labeling Revision | | 050504 | 010 | AP | 1983/06/21 | Labeling Revision | | 050504 | 009 | AP | 1983/06/20 | Labeling Revision | | 050504 | 008 | AP | 1981/11/19 | Control Supplement | | 050504 | 007 | AP | 1983/03/23 | Labeling Revision | | 050504 | 006 | AP | 1983/03/18 | Labeling Revision | | 050504 | 005 | AP | 1983/02/17 | Control Supplement | | 050504 | 004 | AP | 1983/02/01 | Control Supplement | | 050504 | 003 | AP | 1982/12/14 | Control Supplement | | 050504 | 002 | AP | 1982/11/18 | Control Supplement | | 050504 | 001 | AP | 1982/11/17 | Control Supplement | | 050504 | 000 | AP | 1978/09/27 | Approval |
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