| 药品名称 | PREFEST | | 申请号 | 021040 | 产品号 | 001 | | 活性成分 | ESTRADIOL; NORGESTIMATE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 1MG,1MG;N/A,0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1999/10/22 | 申请机构 | TEVA WOMENS HEALTH INC
| | 化学类型 | New combination | 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 | | 021040 | 012 | AP | Letter | 2004/07/21 | 下载 | | 021040 | 012 | AP | Label | 2004/07/21 | 下载 | | 021040 | 010 | AP | Letter | 2004/06/10 | 下载 | | 021040 | 009 | AP | Letter | 2003/12/23 | 下载 | | 021040 | 009 | AP | Label | 2004/02/10 | 下载 | | 021040 | 007 | AP | Letter | 2003/12/23 | 下载 | | 021040 | 007 | AP | Label | 2004/02/10 | 下载 | | 021040 | 005 | AP | Label | 2004/02/10 | 下载 | | 021040 | 005 | AP | Letter | 2003/12/23 | 下载 | | 021040 | 002 | AP | Letter | 2003/12/23 | 下载 | | 021040 | 002 | AP | Label | 2004/02/10 | 下载 | | 021040 | 001 | AP | Letter | 2003/12/23 | 下载 | | 021040 | 001 | AP | Label | 2004/02/10 | 下载 | | 021040 | 000 | AP | Letter | 1999/10/22 | 下载 | | 021040 | 000 | AP | Label | 1999/10/22 | 下载 | | 021040 | 000 | AP | Review | 2005/08/02 | 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 | | 021040 | 012 | AP | 2004/07/12 | Labeling Revision | | 021040 | 011 | AP | 2002/11/13 | Manufacturing Change or Addition | | 021040 | 010 | AP | 2003/01/23 | Labeling Revision | | 021040 | 009 | AP | 2003/12/19 | Labeling Revision | | 021040 | 008 | AP | 2001/10/30 | Labeling Revision | | 021040 | 007 | AP | 2003/12/19 | Labeling Revision | | 021040 | 006 | AP | 2001/01/18 | Manufacturing Change or Addition | | 021040 | 005 | AP | 2003/12/19 | Labeling Revision | | 021040 | 003 | AP | 2000/11/06 | Expiration Date Change | | 021040 | 002 | AP | 2003/12/19 | Labeling Revision | | 021040 | 001 | AP | 2003/12/19 | Labeling Revision | | 021040 | 000 | AP | 1999/10/22 | Approval |
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