药品名称 | ORTHO CYCLEN-28 | 申请号 | 019653 | 产品号 | 002 | 活性成分 | ETHINYL ESTRADIOL; NORGESTIMATE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL-28 | 规格 | 0.035MG;0.25MG | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1989/12/29 | 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 | M-41 | 2008/05/13 | PED | 2008/11/13 |
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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 | 019653 | 056 | AP | Letter | 2015/05/04 | 下载![](pdf.jpg) | 019653 | 056 | AP | Label | 2015/05/04 | 下载![](pdf.jpg) | 019653 | 054 | AP | Letter | 2013/10/04 | 下载![](pdf.jpg) | 019653 | 051 | AP | Letter | 2013/10/04 | 下载![](pdf.jpg) | 019653 | 049 | AP | Letter | 2013/10/04 | 下载![](pdf.jpg) | 019653 | 048 | AP | Letter | 2012/06/20 | 下载![](pdf.jpg) | 019653 | 048 | AP | Label | 2012/07/13 | 下载![](pdf.jpg) | 019653 | 046 | AP | Label | 2013/10/04 | 下载![](pdf.jpg) | 019653 | 046 | AP | Letter | 2013/10/04 | 下载![](pdf.jpg) | 019653 | 045 | AP | Letter | 2008/06/03 | 下载![](pdf.jpg) | 019653 | 037 | AP | Label | 2007/05/07 | 下载![](pdf.jpg) | 019653 | 037 | AP | Letter | 2007/05/09 | 下载![](pdf.jpg) | 019653 | 035 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 033 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 032 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 031 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 030 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 027 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 024 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 023 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 022 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 021 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 020 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 018 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 017 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019653 | 016 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) |
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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 | 019653 | 057 | AP | 2016/06/22 | Manufacturing Change or Addition | 019653 | 056 | AP | 2015/05/01 | Labeling Revision | 019653 | 054 | AP | 2013/10/02 | Labeling Revision | 019653 | 051 | AP | 2013/10/02 | Labeling Revision | 019653 | 049 | AP | 2013/10/02 | Labeling Revision | 019653 | 048 | AP | 2012/06/18 | Labeling Revision | 019653 | 046 | AP | 2013/10/02 | Labeling Revision | 019653 | 045 | AP | 2008/05/30 | Formulation Revision | 019653 | 037 | AP | 2007/05/03 | Labeling Revision | 019653 | 035 | AP | 2003/01/03 | Supplement | 019653 | 033 | AP | 2002/09/06 | Manufacturing Change or Addition | 019653 | 032 | AP | 2002/06/03 | Control Supplement | 019653 | 031 | AP | 2002/01/16 | Manufacturing Change or Addition | 019653 | 030 | AP | 2001/07/09 | Control Supplement | 019653 | 027 | AP | 2001/01/16 | Labeling Revision | 019653 | 025 | AP | 2000/06/05 | Labeling Revision | 019653 | 024 | AP | 2000/01/05 | Package Change | 019653 | 023 | AP | 1999/09/30 | Manufacturing Change or Addition | 019653 | 022 | AP | 1999/11/22 | Labeling Revision | 019653 | 021 | AP | 1999/11/02 | Manufacturing Change or Addition | 019653 | 020 | AP | 1999/10/20 | Control Supplement | 019653 | 018 | AP | 1996/08/21 | Control Supplement | 019653 | 017 | AP | 1998/04/20 | Labeling Revision | 019653 | 016 | AP | 1996/08/02 | Control Supplement | 019653 | 015 | AP | 1996/02/14 | Control Supplement | 019653 | 014 | AP | 1995/11/30 | Manufacturing Change or Addition | 019653 | 013 | AP | 1995/08/21 | Control Supplement | 019653 | 012 | AP | 1996/01/29 | Labeling Revision | 019653 | 011 | AP | 1994/06/28 | Labeling Revision | 019653 | 010 | AP | 1993/11/04 | Manufacturing Change or Addition | 019653 | 009 | AP | 1995/02/16 | Control Supplement | 019653 | 006 | AP | 1992/10/01 | Control Supplement | 019653 | 005 | AP | 1992/06/24 | Manufacturing Change or Addition | 019653 | 003 | AP | 1991/09/17 | Labeling Revision | 019653 | 002 | AP | 1991/05/23 | Control Supplement | 019653 | 001 | AP | 1993/09/30 | Labeling Revision | 019653 | 000 | AP | 1989/12/29 | Approval |
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