| 药品名称 | CENESTIN | | 申请号 | 020992 | 产品号 | 001 | | 活性成分 | ESTROGENS, CONJUGATED SYNTHETIC A | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.3MG | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 2002/06/21 | 申请机构 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
| | 化学类型 | New dosage form | 审评分类 | Standard review drug |
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| 与本品相关的专利信息（来自橙皮书Orange Book） | | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | | 5908638 | 2015/07/26 | | Y | | PDF格式 | | 历史专利信息 | | 无 |
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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 | | 020992 | 034 | AP | Letter | 2015/03/24 | 下载 | | 020992 | 034 | AP | Label | 2015/03/24 | 下载 | | 020992 | 026 | AP | Letter | 2004/10/29 | 下载 | | 020992 | 026 | AP | Label | 2004/11/01 | 下载 | | 020992 | 024 | AP | Letter | 2004/02/02 | 下载 | | 020992 | 021 | AP | Letter | 2004/03/03 | 下载 | | 020992 | 021 | AP | Label | 2004/04/05 | 下载 | | 020992 | 016 | AP | Review | 2007/06/18 | 下载 | | 020992 | 016 | AP | Letter | 2002/06/21 | 下载 | | 020992 | 016 | AP | Label | 2002/06/21 | 下载 | | 020992 | 011 | AP | Letter | 2002/02/22 | 下载 | | 020992 | 000 | AP | Letter | 1999/03/24 | 下载 | | 020992 | 000 | AP | Review | 1999/03/24 | 下载 | | 020992 | 000 | AP | Label | 1999/03/24 | 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 | | 020992 | 034 | AP | 2015/03/20 | Labeling Revision | | 020992 | 026 | AP | 2004/10/28 | Labeling Revision | | 020992 | 024 | AP | 2004/01/28 | Labeling Revision | | 020992 | 023 | AP | 2002/11/05 | Control Supplement | | 020992 | 022 | AP | 2002/10/18 | Manufacturing Change or Addition | | 020992 | 021 | AP | 2004/02/05 | New Dosage Regimen | | 020992 | 020 | AP | 2002/04/29 | Manufacturing Change or Addition | | 020992 | 019 | AP | 2002/03/05 | Control Supplement | | 020992 | 018 | AP | 2002/02/08 | Control Supplement | | 020992 | 017 | AP | 2002/02/08 | Control Supplement | | 020992 | 016 | AP | 2002/06/21 | New or Modified Indication | | 020992 | 015 | AP | 2001/09/05 | Control Supplement | | 020992 | 014 | AP | 2001/09/10 | Control Supplement | | 020992 | 013 | AP | 2001/09/05 | Control Supplement | | 020992 | 012 | AP | 2001/07/20 | Manufacturing Change or Addition | | 020992 | 011 | AP | 2002/02/22 | Labeling Revision | | 020992 | 009 | AP | 2000/08/09 | Control Supplement | | 020992 | 007 | AP | 2000/01/27 | Manufacturing Change or Addition | | 020992 | 006 | AP | 2000/03/13 | Formulation Revision | | 020992 | 005 | AP | 2000/01/07 | Control Supplement | | 020992 | 004 | AP | 1999/11/08 | Control Supplement | | 020992 | 003 | AP | 1999/11/12 | Control Supplement | | 020992 | 002 | AP | 1999/11/02 | Package Change | | 020992 | 001 | AP | 1999/09/07 | Control Supplement | | 020992 | 000 | AP | 1999/03/24 | Approval |
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