| 药品名称 | PLENDIL | | 申请号 | 019834 | 产品号 | 001 | | 活性成分 | FELODIPINE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET, EXTENDED RELEASE;ORAL | 规格 | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1991/07/25 | 申请机构 | ASTRAZENECA PHARMACEUTICALS LP
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
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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 | | 019834 | 025 | AP | Label | 2012/11/02 | 下载 | | 019834 | 025 | AP | Letter | 2012/11/05 | 下载 | | 019834 | 022 | AP | Letter | 2004/06/10 | 下载 | | 019834 | 022 | AP | Label | 2004/06/10 | 下载 | | 019834 | 022 | AP | Review | 2008/04/02 | 下载 | | 019834 | 020 | AP | Review | 2008/04/02 | 下载 | | 019834 | 019 | AP | Review | 2008/08/04 | 下载 | | 019834 | 017 | AP | Review | 2008/08/04 | 下载 | | 019834 | 017 | AP | Letter | 2002/05/22 | 下载 | | 019834 | 017 | AP | Label | 2002/05/22 | 下载 | | 019834 | 016 | AP | Review | 2008/08/08 | 下载 | | 019834 | 014 | AP | Review | 2008/08/04 | 下载 | | 019834 | 013 | AP | Review | 2008/08/08 | 下载 | | 019834 | 012 | AP | Review | 2008/08/11 | 下载 | | 019834 | 009 | AP | Review | 2003/08/07 | 下载 | | 019834 | 009 | AP | Letter | 2004/06/14 | 下载 | | 019834 | 009 | AP | Label | 2004/06/14 | 下载 | | 019834 | 007 | AP | Review | 2008/08/08 | 下载 | | 019834 | 006 | AP | Review | 2008/08/11 | 下载 | | 019834 | 005 | AP | Review | 2008/08/11 | 下载 | | 019834 | 004 | AP | Review | 2008/04/02 | 下载 | | 019834 | 002 | AP | Review | 2003/08/07 | 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 | | 019834 | 025 | AP | 2012/10/31 | Labeling Revision | | 019834 | 022 | AP | 2004/06/07 | Labeling Revision | | 019834 | 020 | AP | 2002/08/26 | Manufacturing Change or Addition | | 019834 | 019 | AP | 2002/09/26 | Control Supplement | | 019834 | 017 | AP | 2002/05/22 | Labeling Revision | | 019834 | 016 | AP | 1999/11/23 | Manufacturing Change or Addition | | 019834 | 015 | AP | 2000/08/28 | Labeling Revision | | 019834 | 014 | AP | 2000/02/08 | Labeling Revision | | 019834 | 013 | AP | 1998/07/14 | Labeling Revision | | 019834 | 012 | AP | 1997/08/07 | Manufacturing Change or Addition | | 019834 | 010 | AP | 1997/10/23 | Package Change | | 019834 | 009 | AP | 1998/01/13 | Labeling Revision | | 019834 | 008 | AP | 1996/12/12 | Control Supplement | | 019834 | 007 | AP | 1996/07/29 | Control Supplement | | 019834 | 006 | AP | 1996/07/03 | Control Supplement | | 019834 | 005 | AP | 1996/02/05 | Package Change | | 019834 | 004 | AP | 1995/07/14 | Labeling Revision | | 019834 | 002 | AP | 1994/09/22 | New Dosage Regimen | | 019834 | 001 | AP | 1993/09/22 | Labeling Revision | | 019834 | 000 | AP | 1991/07/25 | Approval |
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