药品名称 | PRIMAXIN | 申请号 | 062756 | 产品号 | 001 | 活性成分 | CILASTATIN SODIUM; IMIPENEM | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 250MG BASE/VIAL;250MG/VIAL | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1987/01/08 | 申请机构 | MERCK AND CO INC
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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 | 062756 | 038 | AP | Review | 2007/11/19 | 下载 | 062756 | 037 | AP | Review | 2007/11/19 | 下载 | 062756 | 035 | AP | Review | 2007/11/19 | 下载 | 062756 | 034 | AP | Review | 2007/11/19 | 下载 | 062756 | 033 | AP | Review | 2007/11/19 | 下载 | 062756 | 032 | AP | Review | 2007/11/19 | 下载 | 062756 | 030 | AP | Review | 2007/09/26 | 下载 | 062756 | 029 | AP | Review | 2007/09/26 | 下载 | 062756 | 028 | AP | Review | 2007/09/26 | 下载 | 062756 | 027 | AP | Review | 2007/09/26 | 下载 | 062756 | 026 | AP | Review | 2007/09/26 | 下载 | 062756 | 025 | AP | Review | 2007/09/26 | 下载 | 062756 | 024 | AP | Review | 2007/11/19 | 下载 | 062756 | 023 | AP | Review | 2007/09/26 | 下载 | 062756 | 022 | AP | Review | 2007/09/26 | 下载 | 062756 | 021 | AP | Review | 2007/09/26 | 下载 | 062756 | 020 | AP | Review | 2007/09/13 | 下载 | 062756 | 019 | AP | Review | 2007/09/26 | 下载 | 062756 | 018 | AP | Review | 2007/09/26 | 下载 | 062756 | 017 | AP | Review | 2007/09/26 | 下载 | 062756 | 015 | AP | Review | 2007/09/26 | 下载 | 062756 | 014 | AP | Review | 2007/09/26 | 下载 | 062756 | 013 | AP | Review | 2007/09/26 | 下载 | 062756 | 012 | AP | Review | 2007/09/26 | 下载 | 062756 | 011 | AP | Review | 2007/09/26 | 下载 | 062756 | 010 | AP | Review | 2007/08/06 | 下载 | 062756 | 009 | AP | Review | 2007/11/19 | 下载 | 062756 | 008 | AP | Review | 2007/08/06 | 下载 | 062756 | 007 | AP | Review | 2007/08/06 | 下载 | 062756 | 006 | AP | Review | 2007/11/19 | 下载 | 062756 | 005 | AP | Review | 2007/08/06 | 下载 | 062756 | 004 | AP | Review | 2007/11/19 | 下载 | 062756 | 003 | AP | Review | 2007/11/19 | 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 | 062756 | 046 | AP | 2010/04/23 | Labeling Revision | 062756 | 038 | AP | 2002/10/17 | Package Change | 062756 | 037 | AP | 2002/08/20 | Labeling | 062756 | 035 | AP | 2002/04/19 | Facility Addition | 062756 | 034 | AP | 2001/10/11 | Control Supplement | 062756 | 033 | AP | 2001/10/11 | Facility Addition | 062756 | 032 | AP | 2001/09/10 | Manufacturing Revision | 062756 | 031 | AP | 2001/08/31 | Labeling | 062756 | 030 | AP | 1999/11/29 | Chemistry | 062756 | 029 | AP | 1999/01/28 | Labeling | 062756 | 028 | AP | 1998/03/17 | Labeling | 062756 | 027 | AP | 1996/10/31 | Chemistry | 062756 | 026 | AP | 1996/10/11 | Labeling | 062756 | 025 | AP | 1996/05/08 | Chemistry | 062756 | 024 | AP | 2001/08/31 | Labeling | 062756 | 023 | AP | 1997/04/30 | Labeling | 062756 | 022 | AP | 1996/10/11 | Labeling | 062756 | 021 | AP | 1995/05/09 | Chemistry | 062756 | 020 | AP | 1994/09/02 | Chemistry | 062756 | 019 | AP | 1995/07/12 | Labeling in Effect | 062756 | 018 | AP | 1996/10/11 | Labeling in Effect | 062756 | 017 | AP | 1995/07/12 | Labeling | 062756 | 015 | AP | 1992/08/31 | Chemistry | 062756 | 014 | AP | 1993/02/03 | Labeling in Effect | 062756 | 013 | AP | 1992/02/18 | Chemistry | 062756 | 012 | AP | 1992/02/18 | Chemistry in Effect | 062756 | 011 | AP | 1995/07/12 | Labeling | 062756 | 010 | AP | 1993/12/29 | Labeling in Effect | 062756 | 009 | AP | 1991/09/09 | Chemistry Expedite | 062756 | 008 | AP | 1993/12/29 | Labeling | 062756 | 007 | AP | 1993/12/29 | Labeling | 062756 | 006 | AP | 1991/09/09 | Chemistry | 062756 | 005 | AP | 1993/12/29 | Labeling | 062756 | 004 | AP | 1991/02/26 | Chemistry | 062756 | 003 | AP | 1991/03/07 | Labeling | 062756 | 000 | AP | 1987/01/08 | Approval |
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