| 药品名称 | DILACOR XR | | 申请号 | 020092 | 产品号 | 002 | | 活性成分 | DILTIAZEM HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | CAPSULE, EXTENDED RELEASE;ORAL | 规格 | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1992/05/29 | 申请机构 | ALLERGAN SALES LLC
| | 化学类型 | New formulation or new manufacturer | 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 | | 020092 | 017 | AP | Letter | 2011/06/09 | 下载 | | 020092 | 017 | AP | Label | 2011/06/27 | 下载 | | 020092 | 016 | AP | Letter | 2010/06/15 | 下载 | | 020092 | 016 | AP | Label | 2010/06/24 | 下载 | | 020092 | 015 | AP | Letter | 2003/12/16 | 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 | | 020092 | 017 | AP | 2011/06/07 | Labeling Revision | | 020092 | 016 | AP | 2010/06/08 | Labeling Revision | | 020092 | 015 | AP | 2003/12/12 | Labeling Revision | | 020092 | 014 | AP | 2001/08/07 | Manufacturing Change or Addition | | 020092 | 011 | AP | 1998/10/28 | Manufacturing Change or Addition | | 020092 | 010 | AP | 1996/03/20 | Control Supplement | | 020092 | 009 | AP | 1995/10/31 | Manufacturing Change or Addition | | 020092 | 008 | AP | 1995/02/02 | Manufacturing Change or Addition | | 020092 | 007 | AP | 1995/02/09 | Package Change | | 020092 | 006 | AP | 1995/02/09 | Manufacturing Change or Addition | | 020092 | 005 | AP | 1995/03/02 | New or Modified Indication | | 020092 | 004 | AP | 1993/12/06 | Labeling Revision | | 020092 | 003 | AP | 1997/06/19 | Labeling Revision | | 020092 | 002 | AP | 1992/10/15 | Labeling Revision | | 020092 | 001 | AP | 1992/10/02 | Labeling Revision | | 020092 | 000 | AP | 1992/05/29 | Approval |
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