药品名称 | EFFEXOR | 申请号 | 020151 | 产品号 | 006 | 活性成分 | VENLAFAXINE HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1993/12/28 | 申请机构 | WYETH PHARMACEUTICALS INC
| 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 | 020151 | 060 | AP | Label | 2012/12/13 | 下载 | 020151 | 060 | AP | Letter | 2012/12/19 | 下载 | 020151 | 059 | AP | Label | 2012/05/07 | 下载 | 020151 | 059 | AP | Medication Guide | 2012/05/07 | 下载 | 020151 | 059 | AP | Letter | 2012/05/09 | 下载 | 020151 | 058 | AP | Label | 2012/12/13 | 下载 | 020151 | 058 | AP | Letter | 2012/12/19 | 下载 | 020151 | 057 | AP | Letter | 2010/01/14 | 下载 | 020151 | 057 | AP | Label | 2010/01/08 | 下载 | 020151 | 056 | AP | Letter | 2010/01/14 | 下载 | 020151 | 056 | AP | Label | 2010/01/08 | 下载 | 020151 | 055 | AP | Label | 2012/12/13 | 下载 | 020151 | 055 | AP | Letter | 2012/12/19 | 下载 | 020151 | 054 | AP | Letter | 2009/02/03 | 下载 | 020151 | 054 | AP | Label | 2009/02/04 | 下载 | 020151 | 053 | AP | Label | 2009/11/13 | 下载 | 020151 | 053 | AP | Letter | 2010/01/19 | 下载 | 020151 | 052 | AP | Letter | 2008/02/14 | 下载 | 020151 | 052 | AP | Label | 2008/02/14 | 下载 | 020151 | 051 | AP | Letter | 2008/05/28 | 下载 | 020151 | 051 | AP | Label | 2008/11/20 | 下载 | 020151 | 049 | AP | Letter | 2007/09/25 | 下载 | 020151 | 049 | AP | Label | 2007/09/26 | 下载 | 020151 | 047 | AP | Label | 2007/09/26 | 下载 | 020151 | 047 | AP | Letter | 2007/09/25 | 下载 | 020151 | 046 | AP | Letter | 2007/08/02 | 下载 | 020151 | 046 | AP | Label | 2007/08/02 | 下载 | 020151 | 045 | AP | Label | 2006/10/23 | 下载 | 020151 | 045 | AP | Letter | 2006/10/23 | 下载 | 020151 | 044 | AP | Label | 2006/09/15 | 下载 | 020151 | 044 | AP | Letter | 2006/09/20 | 下载 | 020151 | 043 | AP | Letter | 2007/02/12 | 下载 | 020151 | 043 | AP | Label | 2007/02/21 | 下载 | 020151 | 041 | AP | Letter | 2008/02/05 | 下载 | 020151 | 039 | AP | Letter | 2006/01/20 | 下载 | 020151 | 038 | AP | Letter | 2006/01/20 | 下载 | 020151 | 035 | AP | Letter | 2005/02/23 | 下载 | 020151 | 034 | AP | Letter | 2006/03/01 | 下载 | 020151 | 033 | AP | Label | 2007/08/02 | 下载 | 020151 | 032 | AP | Letter | 2004/05/26 | 下载 | 020151 | 032 | AP | Label | 2004/05/27 | 下载 | 020151 | 032 | AP | Review | 2007/11/19 | 下载 | 020151 | 031 | AP | Label | 2012/12/13 | 下载 | 020151 | 031 | AP | Letter | 2012/12/19 | 下载 | 020151 | 030 | AP | Review | 2007/11/19 | 下载 | 020151 | 030 | AP | Label | 2004/05/27 | 下载 | 020151 | 030 | AP | Letter | 2004/05/26 | 下载 | 020151 | 029 | AP | Letter | 2004/04/20 | 下载 | 020151 | 028 | AP | Letter | 2004/05/26 | 下载 | 020151 | 028 | AP | Label | 2004/05/27 | 下载 | 020151 | 028 | AP | Review | 2007/11/19 | 下载 | 020151 | 027 | AP | Letter | 2004/03/24 | 下载 | 020151 | 025 | AP | Review | 2007/07/05 | 下载 | 020151 | 024 | AP | Letter | 2004/05/07 | 下载 | 020151 | 023 | AP | Review | 2007/07/05 | 下载 | 020151 | 022 | AP | Review | 2007/07/05 | 下载 | 020151 | 021 | AP | Review | 2007/07/05 | 下载 | 020151 | 020 | AP | Review | 2007/07/05 | 下载 | 020151 | 019 | AP | Review | 2007/07/05 | 下载 | 020151 | 018 | AP | Letter | 2003/07/30 | 下载 | 020151 | 018 | AP | Label | 2004/06/02 | 下载 | 020151 | 018 | AP | Review | 2007/07/06 | 下载 | 020151 | 017 | AP | Label | 2003/04/24 | 下载 | 020151 | 017 | AP | Letter | 2003/07/30 | 下载 | 020151 | 017 | AP | Review | 2007/07/06 | 下载 | 020151 | 016 | AP | Review | 2007/07/05 | 下载 | 020151 | 000 | AP | Other Important Information from FDA | 2005/04/15 | 下载 | 020151 | 000 | AP | Medication Guide | 2009/11/18 | 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 | 020151 | 060 | AP | 2012/12/12 | Labeling Revision | 020151 | 059 | AP | 2012/05/02 | Labeling Revision | 020151 | 058 | AP | 2012/12/12 | Labeling Revision | 020151 | 057 | AP | 2010/01/06 | Labeling Revision | 020151 | 056 | AP | 2010/01/06 | Labeling Revision | 020151 | 055 | AP | 2012/12/12 | Labeling Revision | 020151 | 054 | AP | 2009/01/30 | Labeling Revision | 020151 | 053 | AP | 2009/11/09 | Labeling Revision | 020151 | 052 | AP | 2008/02/11 | Labeling Revision | 020151 | 051 | AP | 2008/05/23 | Labeling Revision | 020151 | 050 | AP | 2008/02/07 | Labeling Revision | 020151 | 049 | AP | 2007/09/20 | Labeling Revision | 020151 | 047 | AP | 2007/09/20 | Labeling Revision | 020151 | 046 | AP | 2007/08/01 | Labeling Revision | 020151 | 045 | AP | 2006/10/20 | Labeling Revision | 020151 | 044 | AP | 2006/09/14 | Labeling Revision | 020151 | 043 | AP | 2007/02/07 | Labeling Revision | 020151 | 041 | AP | 2008/01/30 | Labeling Revision | 020151 | 039 | AP | 2006/01/12 | Labeling Revision | 020151 | 038 | AP | 2006/01/12 | Labeling Revision | 020151 | 035 | AP | 2005/02/18 | Labeling Revision | 020151 | 034 | AP | 2006/02/24 | Labeling Revision | 020151 | 033 | AP | 2007/08/01 | Labeling Revision | 020151 | 032 | AP | 2004/05/13 | Labeling Revision | 020151 | 031 | AP | 2012/12/12 | Labeling Revision | 020151 | 030 | AP | 2004/05/13 | Labeling Revision | 020151 | 029 | AP | 2004/04/08 | Labeling Revision | 020151 | 028 | AP | 2004/05/13 | Labeling Revision | 020151 | 027 | AP | 2004/03/19 | Labeling Revision | 020151 | 025 | AP | 2003/01/31 | Supplement | 020151 | 024 | AP | 2004/05/05 | Patient Population Altered | 020151 | 023 | AP | 2003/01/31 | Supplement | 020151 | 022 | AP | 2003/01/31 | Supplement | 020151 | 021 | AP | 2003/01/31 | Supplement | 020151 | 020 | AP | 2003/01/31 | Supplement | 020151 | 019 | AP | 2003/01/31 | Supplement | 020151 | 018 | AP | 2001/05/02 | New or Modified Indication | 020151 | 017 | AP | 2001/05/02 | New or Modified Indication | 020151 | 016 | AP | 2003/01/31 | Supplement | 020151 | 015 | AP | 2000/07/20 | Labeling Revision | 020151 | 014 | AP | 2000/03/03 | Labeling Revision | 020151 | 013 | AP | 2000/07/20 | Labeling Revision | 020151 | 012 | AP | 1999/10/04 | Control Supplement | 020151 | 011 | AP | 2000/07/20 | Labeling Revision | 020151 | 009 | AP | 1998/12/09 | Labeling Revision | 020151 | 008 | AP | 1998/12/09 | Labeling Revision | 020151 | 007 | AP | 1998/12/09 | Labeling Revision | 020151 | 006 | AP | 1998/12/09 | Labeling Revision | 020151 | 005 | AP | 1996/06/25 | Labeling Revision | 020151 | 003 | AP | 1994/11/16 | Control Supplement | 020151 | 002 | AP | 1994/11/28 | Labeling Revision | 020151 | 001 | AP | 1994/11/16 | Control Supplement | 020151 | 000 | AP | 1993/12/28 | Approval |
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