药品名称 | ORTHO EVRA | 申请号 | 021180 | 产品号 | 001 | 活性成分 | ETHINYL ESTRADIOL; NORELGESTROMIN | 市场状态 | 停止上市 | 剂型或给药途径 | FILM, EXTENDED RELEASE;TRANSDERMAL | 规格 | 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 2001/11/20 | 申请机构 | JANSSEN PHARMACEUTICALS INC
| 化学类型 | | 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 | 021180 | 047 | AP | Letter | 2015/10/23 | 下载 | 021180 | 047 | AP | Label | 2015/10/26 | 下载 | 021180 | 046 | AP | Letter | 2014/04/14 | 下载 | 021180 | 046 | AP | Label | 2014/04/14 | 下载 | 021180 | 044 | AP | Letter | 2013/07/03 | 下载 | 021180 | 044 | AP | Label | 2013/07/03 | 下载 | 021180 | 043 | AP | Label | 2012/08/22 | 下载 | 021180 | 043 | AP | Letter | 2012/08/24 | 下载 | 021180 | 040 | AP | Label | 2011/12/28 | 下载 | 021180 | 040 | AP | Letter | 2012/01/03 | 下载 | 021180 | 039 | AP | Letter | 2011/03/25 | 下载 | 021180 | 039 | AP | Label | 2011/03/28 | 下载 | 021180 | 038 | AP | Letter | 2011/07/28 | 下载 | 021180 | 038 | AP | Label | 2011/08/12 | 下载 | 021180 | 035 | AP | Letter | 2010/04/19 | 下载 | 021180 | 035 | AP | Label | 2010/04/19 | 下载 | 021180 | 034 | AP | Label | 2009/12/02 | 下载 | 021180 | 034 | AP | Letter | 2010/01/25 | 下载 | 021180 | 033 | AP | Label | 2009/09/17 | 下载 | 021180 | 033 | AP | Letter | 2009/11/10 | 下载 | 021180 | 031 | AP | Letter | 2008/11/03 | 下载 | 021180 | 031 | AP | Label | 2008/11/07 | 下载 | 021180 | 030 | AP | Letter | 2008/11/03 | 下载 | 021180 | 030 | AP | Label | 2008/11/07 | 下载 | 021180 | 029 | AP | Label | 2009/08/13 | 下载 | 021180 | 029 | AP | Letter | 2009/11/10 | 下载 | 021180 | 028 | AP | Label | 2008/11/07 | 下载 | 021180 | 028 | AP | Letter | 2008/11/03 | 下载 | 021180 | 026 | AP | Label | 2008/01/18 | 下载 | 021180 | 022 | AP | Label | 2006/09/20 | 下载 | 021180 | 022 | AP | Letter | 2006/09/20 | 下载 | 021180 | 020 | AP | Letter | 2006/05/21 | 下载 | 021180 | 019 | AP | Label | 2005/11/10 | 下载 | 021180 | 019 | AP | Letter | 2005/11/18 | 下载 | 021180 | 015 | AP | Letter | 2005/05/17 | 下载 | 021180 | 015 | AP | Label | 2005/05/17 | 下载 | 021180 | 014 | AP | Letter | 2004/12/02 | 下载 | 021180 | 008 | AP | Letter | 2004/03/02 | 下载 | 021180 | 008 | AP | Review | 2008/07/31 | 下载 | 021180 | 005 | AP | Review | 2007/06/29 | 下载 | 021180 | 004 | AP | Review | 2006/07/11 | 下载 | 021180 | 003 | AP | Review | 2006/07/11 | 下载 | 021180 | 002 | AP | Review | 2008/08/01 | 下载 | 021180 | 001 | AP | Review | 2008/08/01 | 下载 | 021180 | 000 | AP | Other Important Information from FDA | 2006/09/22 | 下载 | 021180 | 000 | AP | Letter | 2001/11/20 | 下载 | 021180 | 000 | AP | Label | 2001/11/20 | 下载 | 021180 | 000 | AP | Review | 2001/11/20 | 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 | 021180 | 047 | AP | 2015/10/22 | Labeling Revision | 021180 | 046 | AP | 2014/04/11 | Labeling Revision | 021180 | 044 | AP | 2013/07/01 | Labeling Revision | 021180 | 043 | AP | 2012/08/22 | Labeling Revision | 021180 | 041 | AP | 2013/04/12 | Manufacturing Change or Addition | 021180 | 040 | AP | 2011/12/28 | Labeling Revision | 021180 | 039 | AP | 2011/03/23 | Labeling Revision | 021180 | 038 | AP | 2011/07/26 | Labeling Revision | 021180 | 037 | AP | 2013/04/12 | Manufacturing Change or Addition | 021180 | 035 | AP | 2010/04/13 | Labeling Revision | 021180 | 034 | AP | 2009/12/01 | Labeling Revision | 021180 | 033 | AP | 2009/09/11 | Labeling Revision | 021180 | 031 | AP | 2008/10/30 | Labeling Revision | 021180 | 030 | AP | 2008/10/30 | Labeling Revision | 021180 | 029 | AP | 2009/07/29 | Supplement | 021180 | 028 | AP | 2008/10/30 | Labeling Revision | 021180 | 026 | AP | 2008/01/18 | Labeling Revision | 021180 | 022 | AP | 2006/09/20 | Labeling Revision | 021180 | 020 | AP | 2006/05/17 | Labeling Revision | 021180 | 019 | AP | 2005/11/10 | Labeling Revision | 021180 | 015 | AP | 2005/05/06 | Labeling Revision | 021180 | 014 | AP | 2004/11/24 | Control Supplement | 021180 | 008 | AP | 2004/02/04 | Labeling Revision | 021180 | 005 | AP | 2002/06/18 | Control Supplement | 021180 | 004 | AP | 2002/10/02 | Manufacturing Change or Addition | 021180 | 003 | AP | 2002/11/14 | Manufacturing Change or Addition | 021180 | 002 | AP | 2002/08/09 | Manufacturing Change or Addition | 021180 | 001 | AP | 2002/03/04 | Control Supplement | 021180 | 000 | AP | 2001/11/20 | Approval |
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