| 药品名称 | NOVANTRONE | | 申请号 | 019297 | 产品号 | 003 | | 活性成分 | MITOXANTRONE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1987/12/23 | 申请机构 | EMD SERONO INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug | | 罕用药/孤儿药 | 是 | | |
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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 | | ODE | 2007/10/13 |
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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 | | 019297 | 035 | AP | Letter | 2012/03/26 | 下载 | | 019297 | 035 | AP | Label | 2012/03/27 | 下载 | | 019297 | 035 | AP | Medication Guide | 2012/03/27 | 下载 | | 019297 | 034 | AP | Label | 2010/06/24 | 下载 | | 019297 | 034 | AP | Letter | 2010/06/16 | 下载 | | 019297 | 033 | AP | Label | 2010/06/24 | 下载 | | 019297 | 033 | AP | Letter | 2010/06/16 | 下载 | | 019297 | 031 | AP | Letter | 2009/02/13 | 下载 | | 019297 | 031 | AP | Label | 2009/02/12 | 下载 | | 019297 | 030 | AP | Letter | 2009/02/13 | 下载 | | 019297 | 030 | AP | Label | 2009/02/12 | 下载 | | 019297 | 029 | AP | Letter | 2007/04/20 | 下载 | | 019297 | 028 | AP | Letter | 2005/04/28 | 下载 | | 019297 | 028 | AP | Label | 2005/04/28 | 下载 | | 019297 | 027 | AP | Letter | 2003/01/13 | 下载 | | 019297 | 026 | AP | Letter | 2003/01/13 | 下载 | | 019297 | 025 | AP | Letter | 2003/01/13 | 下载 | | 019297 | 024 | AP | Letter | 2002/02/20 | 下载 | | 019297 | 021 | AP | Review | 2000/02/04 | 下载 | | 019297 | 014 | AP | Review | 1997/11/20 | 下载 | | 019297 | 000 | AP | Review | 2008/04/04 | 下载 | | 019297 | 000 | AP | Other Important Information from FDA | 2008/07/29 | 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 | | 019297 | 035 | AP | 2012/03/23 | Labeling Revision | | 019297 | 034 | AP | 2010/06/13 | Labeling Revision | | 019297 | 033 | AP | 2010/06/13 | Labeling Revision | | 019297 | 031 | AP | 2009/02/11 | Labeling Revision | | 019297 | 030 | AP | 2009/02/11 | Labeling Revision | | 019297 | 029 | AP | 2007/04/11 | Manufacturing Change or Addition | | 019297 | 028 | AP | 2005/04/27 | Labeling Revision | | 019297 | 027 | AP | 2003/01/13 | Labeling Revision | | 019297 | 026 | AP | 2003/01/13 | Labeling Revision | | 019297 | 025 | AP | 2003/01/13 | Labeling Revision | | 019297 | 024 | AP | 2002/02/20 | Labeling Revision | | 019297 | 023 | AP | 2001/02/09 | Control Supplement | | 019297 | 022 | AP | 2001/01/31 | Labeling Revision | | 019297 | 021 | AP | 2000/02/04 | Labeling Revision | | 019297 | 020 | AP | 2000/10/19 | Control Supplement | | 019297 | 019 | AP | 1998/05/08 | Labeling Revision | | 019297 | 018 | AP | 1997/09/19 | Labeling Revision | | 019297 | 017 | AP | 1998/08/13 | Manufacturing Change or Addition | | 019297 | 016 | AP | 1997/05/23 | Labeling Revision | | 019297 | 015 | AP | 1997/05/08 | Control Supplement | | 019297 | 014 | AP | 1996/11/13 | New or Modified Indication | | 019297 | 012 | AP | 1996/10/18 | Labeling Revision | | 019297 | 011 | AP | 1995/04/10 | Control Supplement | | 019297 | 010 | AP | 1994/09/23 | Labeling Revision | | 019297 | 009 | AP | 1994/04/15 | Control Supplement | | 019297 | 008 | AP | 1990/07/30 | Control Supplement | | 019297 | 006 | AP | 1992/02/19 | Manufacturing Change or Addition | | 019297 | 005 | AP | 1990/02/22 | Package Change | | 019297 | 002 | AP | 1990/11/26 | Control Supplement | | 019297 | 001 | AP | 1988/03/17 | Manufacturing Change or Addition | | 019297 | 000 | AP | 1987/12/23 | Approval |
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