药品名称 | VIBRA-TABS | 申请号 | 050533 | 产品号 | 001 | 活性成分 | DOXYCYCLINE HYCLATE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | PFIZER LABORATORIES DIV PFIZER INC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 | 无 | 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 | 050533 | 043 | AP | Letter | 2016/04/05 | 下载 | 050533 | 043 | AP | Label | 2016/04/07 | 下载 | 050533 | 042 | AP | Letter | 2014/09/16 | 下载 | 050533 | 042 | AP | Label | 2014/10/02 | 下载 | 050533 | 041 | AP | Letter | 2013/09/09 | 下载 | 050533 | 041 | AP | Label | 2013/09/09 | 下载 | 050533 | 040 | AP | Letter | 2013/04/30 | 下载 | 050533 | 040 | AP | Label | 2013/05/01 | 下载 | 050533 | 038 | AP | Label | 2011/05/16 | 下载 | 050533 | 036 | AP | Letter | 2008/02/13 | 下载 | 050533 | 036 | AP | Label | 2008/02/14 | 下载 | 050533 | 032 | AP | Letter | 2004/03/16 | 下载 | 050533 | 030 | AP | Letter | 2002/06/18 | 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 | 050533 | 043 | AP | 2016/03/31 | Labeling Revision | 050533 | 042 | AP | 2014/09/12 | Labeling Revision | 050533 | 041 | AP | 2013/09/04 | Labeling Revision | 050533 | 040 | AP | 2013/04/29 | Labeling Revision | 050533 | 038 | AP | 2011/05/11 | Labeling Revision | 050533 | 036 | AP | 2008/02/06 | Labeling Revision | 050533 | 032 | AP | 2004/03/12 | Labeling Revision | 050533 | 031 | AP | 2002/05/15 | Manufacturing Change or Addition | 050533 | 030 | AP | 2002/06/18 | Labeling Revision | 050533 | 029 | AP | 2000/03/06 | Package Change | 050533 | 028 | AP | 1998/05/08 | Control Supplement | 050533 | 027 | AP | 1992/12/15 | New or Modified Indication | 050533 | 026 | AP | 1992/05/11 | Labeling Revision | 050533 | 025 | AP | 1984/05/22 | Expiration Date Change | 050533 | 024 | AP | 1984/02/13 | New or Modified Indication | 050533 | 023 | AP | 1984/01/17 | New or Modified Indication | 050533 | 021 | AP | 1983/11/21 | Labeling Revision | 050533 | 020 | AP | 1983/04/01 | Labeling Revision | 050533 | 019 | AP | 1982/08/31 | Labeling Revision | 050533 | 018 | AP | 1982/04/02 | Package Change | 050533 | 017 | AP | 1982/02/16 | Package Change | 050533 | 016 | AP | 1982/02/25 | Control Supplement | 050533 | 015 | AP | 1981/12/17 | Formulation Revision | 050533 | 014 | AP | 1981/12/15 | Control Supplement | 050533 | 013 | AP | 1981/06/30 | Control Supplement | 050533 | 012 | AP | 1981/03/11 | Control Supplement | 050533 | 011 | AP | 1992/05/07 | Labeling Revision | 050533 | 010 | AP | 1991/07/24 | Expiration Date Change | 050533 | 009 | AP | 1991/08/23 | Labeling Revision | 050533 | 008 | AP | 1981/02/05 | Control Supplement | 050533 | 007 | AP | 1981/04/02 | Expiration Date Change | 050533 | 006 | AP | 1980/10/21 | Control Supplement | 050533 | 005 | AP | 1980/08/12 | Labeling Revision | 050533 | 004 | AP | 1980/07/25 | Control Supplement | 050533 | 003 | AP | 1981/02/26 | Control Supplement | 050533 | 002 | AP | 1980/04/01 | Labeling Revision | 050533 | 001 | AP | 1980/01/21 | Expiration Date Change | 050533 | 000 | AP | 1980/01/15 | Approval |
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