| 药品名称 | KYTRIL | | 申请号 | 020239 | 产品号 | 001 | | 活性成分 | GRANISETRON HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1993/12/29 | 申请机构 | HOFFMANN LA ROCHE INC
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
|
|
|
| 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 | | M-102 | 2014/04/29 |
|
| 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 | | 020239 | 023 | AP | Label | 2011/05/02 | 下载 | | 020239 | 023 | AP | Letter | 2011/09/19 | 下载 | | 020239 | 021 | AP | Label | 2009/10/14 | 下载 | | 020239 | 021 | AP | Letter | 2009/11/12 | 下载 | | 020239 | 018 | AP | Review | 2009/09/16 | 下载 | | 020239 | 018 | AP | Label | 2005/11/30 | 下载 | | 020239 | 018 | AP | Letter | 2005/11/30 | 下载 | | 020239 | 017 | AP | Letter | 2004/09/21 | 下载 | | 020239 | 017 | AP | Review | 2009/09/16 | 下载 | | 020239 | 016 | AP | Review | 2009/09/16 | 下载 | | 020239 | 016 | AP | Letter | 2004/09/21 | 下载 | | 020239 | 015 | AP | Letter | 2004/08/25 | 下载 | | 020239 | 015 | AP | Label | 2004/08/25 | 下载 | | 020239 | 015 | AP | Review | 2009/01/12 | 下载 | | 020239 | 008 | AP | Letter | 2002/08/16 | 下载 | | 020239 | 008 | AP | Label | 2002/08/16 | 下载 | | 020239 | 007 | AP | Review | 2008/08/11 | 下载 |
|
| 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 | | 020239 | 023 | AP | 2011/04/29 | Efficacy Supplement with Clinical Data to Support | | 020239 | 021 | AP | 2009/10/07 | Labeling Revision | | 020239 | 018 | AP | 2005/11/23 | Labeling Revision | | 020239 | 017 | AP | 2004/09/17 | Manufacturing Change or Addition | | 020239 | 016 | AP | 2004/09/17 | Formulation Revision | | 020239 | 015 | AP | 2004/08/20 | Formulation Revision | | 020239 | 011 | AP | 2002/11/25 | Control Supplement | | 020239 | 009 | AP | 2002/11/05 | Manufacturing Change or Addition | | 020239 | 008 | AP | 2002/08/16 | New or Modified Indication | | 020239 | 007 | AP | 1997/03/20 | Labeling Revision | | 020239 | 006 | AP | 1997/05/30 | Formulation Revision | | 020239 | 005 | AP | 1996/10/24 | Manufacturing Change or Addition | | 020239 | 004 | AP | 1997/01/21 | New Dosage Regimen | | 020239 | 003 | AP | 1995/11/21 | Labeling Revision | | 020239 | 002 | AP | 1997/01/21 | Labeling Revision | | 020239 | 001 | AP | 1994/03/11 | Formulation Revision | | 020239 | 000 | AP | 1993/12/29 | Approval |
|