药品名称 | ZOFRAN | 申请号 | 020007 | 产品号 | 001 | 活性成分 | ONDANSETRON HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 2MG BASE/ML | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1991/01/04 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 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 | 4753789*PED | 2006/12/24 | | | | PDF格式 |
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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 | D-97 | 2008/03/25 | D-98 | 2008/03/25 | PED | 2008/09/25 |
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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 | 020007 | 046 | AP | Label | 2014/09/22 | 下载 | 020007 | 046 | AP | Letter | 2014/09/23 | 下载 | 020007 | 044 | AP | Label | 2013/12/11 | 下载 | 020007 | 044 | AP | Letter | 2013/12/13 | 下载 | 020007 | 043 | AP | Label | 2012/11/15 | 下载 | 020007 | 043 | AP | Letter | 2012/11/16 | 下载 | 020007 | 042 | AP | Letter | 2011/09/16 | 下载 | 020007 | 042 | AP | Label | 2011/09/16 | 下载 | 020007 | 041 | AP | Letter | 2011/07/13 | 下载 | 020007 | 040 | AP | Letter | 2010/09/28 | 下载 | 020007 | 040 | AP | Label | 2010/09/29 | 下载 | 020007 | 039 | AP | Label | 2006/08/23 | 下载 | 020007 | 039 | AP | Letter | 2006/09/18 | 下载 | 020007 | 037 | AP | Label | 2006/01/05 | 下载 | 020007 | 037 | AP | Review | 2009/09/16 | 下载 | 020007 | 035 | AP | Letter | 2005/03/30 | 下载 | 020007 | 035 | AP | Label | 2005/03/30 | 下载 | 020007 | 034 | AP | Letter | 2004/12/02 | 下载 | 020007 | 034 | AP | Label | 2004/12/03 | 下载 | 020007 | 030 | AP | Review | 2009/01/12 | 下载 | 020007 | 022 | AP | Review | 1997/10/31 | 下载 | 020007 | 000 | AP | Other | 2007/07/09 | 下载 | 020007 | 000 | AP | Other | 2011/12/20 | 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 | 020007 | 046 | AP | 2014/09/18 | Labeling Revision | 020007 | 044 | AP | 2013/12/10 | Labeling Revision | 020007 | 043 | AP | 2012/11/14 | Labeling Revision | 020007 | 042 | AP | 2011/09/14 | Labeling Revision | 020007 | 041 | AP | 2011/07/07 | Labeling Revision | 020007 | 040 | AP | 2010/09/22 | Labeling Revision | 020007 | 039 | AP | 2006/08/22 | Labeling Revision | 020007 | 037 | AP | 2005/12/27 | Labeling Revision | 020007 | 035 | AP | 2005/03/25 | Patient Population Altered | 020007 | 034 | AP | 2004/11/24 | Labeling Revision | 020007 | 032 | AP | 2000/12/08 | Labeling Revision | 020007 | 031 | AP | 2000/12/08 | Labeling Revision | 020007 | 030 | AP | 2000/04/11 | Labeling Revision | 020007 | 029 | AP | 1999/05/14 | Manufacturing Change or Addition | 020007 | 028 | AP | 1999/02/17 | Labeling Revision | 020007 | 027 | AP | 1999/03/10 | Labeling Revision | 020007 | 024 | AP | 1997/08/12 | Manufacturing Change or Addition | 020007 | 023 | AP | 1997/04/02 | Labeling Revision | 020007 | 022 | AP | 1997/10/31 | New Route of Administration | 020007 | 021 | AP | 1996/03/12 | Labeling Revision | 020007 | 020 | AP | 1996/05/16 | New or Modified Indication | 020007 | 019 | AP | 1996/07/29 | Package Change | 020007 | 018 | AP | 1995/02/14 | Manufacturing Change or Addition | 020007 | 016 | AP | 1994/04/27 | Labeling Revision | 020007 | 015 | AP | 1994/03/31 | Manufacturing Change or Addition | 020007 | 014 | AP | 1995/01/31 | Formulation Revision | 020007 | 013 | AP | 1993/04/28 | Labeling Revision | 020007 | 012 | AP | 1993/02/09 | Control Supplement | 020007 | 011 | AP | 1993/03/24 | Control Supplement | 020007 | 010 | AP | 1993/01/22 | Control Supplement | 020007 | 009 | AP | 1993/12/10 | Formulation Revision | 020007 | 008 | AP | 1993/02/02 | Labeling Revision | 020007 | 007 | AP | 1993/02/02 | Labeling Revision | 020007 | 006 | AP | 1992/08/18 | Control Supplement | 020007 | 005 | AP | 1993/08/13 | New or Modified Indication | 020007 | 004 | AP | 1993/02/02 | Labeling Revision | 020007 | 003 | AP | 1993/02/02 | New Dosage Regimen | 020007 | 002 | AP | 1993/02/02 | Labeling Revision | 020007 | 001 | AP | 1993/02/02 | Labeling Revision | 020007 | 000 | AP | 1991/01/04 | Approval |
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