| 药品名称 | AGENERASE | | 申请号 | 021039 | 产品号 | 001 | | 活性成分 | AMPRENAVIR | 市场状态 | 停止上市 | | 剂型或给药途径 | SOLUTION;ORAL | 规格 | 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1999/04/15 | 申请机构 | GLAXOSMITHKLINE
| | 化学类型 | New dosage form | 审评分类 | |
|
|
|
| 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 |
|
| 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 | | 021039 | 017 | AP | Label | 2005/11/08 | 下载 | | 021039 | 017 | AP | Letter | 2005/11/18 | 下载 | | 021039 | 016 | AP | Letter | 2004/03/02 | 下载 | | 021039 | 016 | AP | Label | 2004/04/05 | 下载 | | 021039 | 014 | AP | Letter | 2002/10/02 | 下载 | | 021039 | 014 | AP | Label | 2002/10/02 | 下载 | | 021039 | 013 | AP | Letter | 2002/10/02 | 下载 | | 021039 | 013 | AP | Label | 2002/10/02 | 下载 | | 021039 | 012 | AP | Letter | 2002/02/05 | 下载 | | 021039 | 010 | AP | Letter | 2002/08/02 | 下载 | | 021039 | 010 | AP | Label | 2002/08/02 | 下载 | | 021039 | 009 | AP | Letter | 2002/02/05 | 下载 | | 021039 | 006 | AP | Letter | 2001/05/11 | 下载 | | 021039 | 006 | AP | Label | 2001/05/11 | 下载 | | 021039 | 006 | AP | Review | 2004/05/26 | 下载 | | 021039 | 000 | AP | Review | 2004/05/26 | 下载 | | 021039 | 000 | AP | Letter | 1999/04/15 | 下载 | | 021039 | 000 | AP | Label | 1999/04/15 | 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 | | 021039 | 017 | AP | 2005/11/04 | Labeling Revision | | 021039 | 016 | AP | 2004/02/12 | Labeling Revision | | 021039 | 015 | AP | 2002/12/24 | Manufacturing Change or Addition | | 021039 | 014 | AP | 2002/10/02 | Labeling Revision | | 021039 | 013 | AP | 2002/10/02 | Labeling Revision | | 021039 | 012 | AP | 2002/02/05 | Labeling Revision | | 021039 | 010 | AP | 2002/08/02 | Labeling Revision | | 021039 | 009 | AP | 2002/02/05 | Efficacy Supplement with Clinical Data to Support | | 021039 | 008 | AP | 2001/05/09 | Labeling Revision | | 021039 | 006 | AP | 2001/05/11 | Accelerated Approval | | 021039 | 005 | AP | 2000/12/19 | Labeling Revision | | 021039 | 004 | AP | 1999/12/22 | Manufacturing Change or Addition | | 021039 | 003 | AP | 2000/04/24 | Labeling Revision | | 021039 | 002 | AP | 2000/04/28 | Labeling Revision | | 021039 | 001 | AP | 1999/09/22 | Labeling Revision | | 021039 | 000 | AP | 1999/04/15 | Approval |
|