| 药品名称 | ORTHO TRI-CYCLEN | | 申请号 | 019697 | 产品号 | 001 | | 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,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | | 治疗等效代码 | AB | 参比药物 | 是 | | 批准日期 | 1992/07/03 | 申请机构 | JANSSEN PHARMACEUTICALS 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 | | 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 | | 019697 | 052 | AP | Letter | 2015/05/04 | 下载 | | 019697 | 052 | AP | Label | 2015/05/04 | 下载 | | 019697 | 050 | AP | Letter | 2013/10/04 | 下载 | | 019697 | 047 | AP | Label | 2013/10/04 | 下载 | | 019697 | 047 | AP | Letter | 2013/10/04 | 下载 | | 019697 | 045 | AP | Letter | 2013/10/04 | 下载 | | 019697 | 044 | AP | Letter | 2012/06/20 | 下载 | | 019697 | 044 | AP | Label | 2012/07/13 | 下载 | | 019697 | 042 | AP | Letter | 2013/10/04 | 下载 | | 019697 | 042 | AP | Label | 2013/11/20 | 下载 | | 019697 | 041 | AP | Letter | 2008/06/03 | 下载 | | 019697 | 034 | AP | Label | 2007/05/07 | 下载 | | 019697 | 034 | AP | Letter | 2007/05/09 | 下载 | | 019697 | 032 | AP | Review | 2009/01/12 | 下载 | | 019697 | 030 | AP | Review | 2009/01/12 | 下载 | | 019697 | 029 | AP | Review | 2009/01/12 | 下载 | | 019697 | 028 | AP | Review | 2009/01/12 | 下载 | | 019697 | 027 | AP | Review | 2009/01/12 | 下载 | | 019697 | 025 | AP | Review | 2009/01/12 | 下载 | | 019697 | 024 | AP | Review | 2009/01/12 | 下载 | | 019697 | 021 | AP | Review | 2009/01/12 | 下载 | | 019697 | 019 | AP | Review | 2009/01/12 | 下载 | | 019697 | 018 | AP | Review | 2009/01/12 | 下载 | | 019697 | 016 | AP | Review | 2009/01/12 | 下载 | | 019697 | 015 | AP | Review | 2009/01/12 | 下载 | | 019697 | 013 | AP | Review | 2009/01/12 | 下载 | | 019697 | 011 | AP | Review | 2009/01/12 | 下载 | | 019697 | 010 | AP | Review | 2009/01/12 | 下载 | | 019697 | 009 | AP | Review | 2009/01/12 | 下载 | | 019697 | 005 | AP | Review | 2009/01/12 | 下载 | | 019697 | 004 | AP | Review | 2009/01/12 | 下载 | | 019697 | 002 | AP | Review | 2009/01/12 | 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 | | 019697 | 052 | AP | 2015/05/01 | Labeling Revision | | 019697 | 050 | AP | 2013/10/02 | Labeling Revision | | 019697 | 047 | AP | 2013/10/02 | Labeling Revision | | 019697 | 045 | AP | 2013/10/02 | Labeling Revision | | 019697 | 044 | AP | 2012/06/18 | Labeling Revision | | 019697 | 042 | AP | 2013/10/02 | Labeling Revision | | 019697 | 041 | AP | 2008/05/30 | Formulation Revision | | 019697 | 034 | AP | 2007/05/03 | Labeling Revision | | 019697 | 032 | AP | 2003/01/03 | Control Supplement | | 019697 | 030 | AP | 2002/09/06 | Manufacturing Change or Addition | | 019697 | 029 | AP | 2002/06/03 | Control Supplement | | 019697 | 028 | AP | 2002/01/16 | Manufacturing Change or Addition | | 019697 | 027 | AP | 2001/07/09 | Control Supplement | | 019697 | 025 | AP | 2000/08/30 | Expiration Date Change | | 019697 | 024 | AP | 2001/01/16 | Labeling Revision | | 019697 | 022 | AP | 2000/06/05 | Labeling Revision | | 019697 | 021 | AP | 2000/01/05 | Package Change | | 019697 | 019 | AP | 1999/09/30 | Manufacturing Change or Addition | | 019697 | 018 | AP | 1999/11/22 | Labeling Revision | | 019697 | 016 | AP | 1999/11/02 | Manufacturing Change or Addition | | 019697 | 015 | AP | 1999/10/20 | Control Supplement | | 019697 | 013 | AP | 1996/08/21 | Control Supplement | | 019697 | 012 | AP | 1998/04/20 | Labeling Revision | | 019697 | 011 | AP | 1996/08/02 | Control Supplement | | 019697 | 010 | AP | 1996/02/14 | Control Supplement | | 019697 | 009 | AP | 1996/02/07 | Control Supplement | | 019697 | 008 | AP | 1995/11/30 | Manufacturing Change or Addition | | 019697 | 007 | AP | 1995/08/21 | Control Supplement | | 019697 | 006 | AP | 1995/08/21 | Expiration Date Change | | 019697 | 005 | AP | 1996/01/29 | Labeling Revision | | 019697 | 004 | AP | 1994/12/28 | Manufacturing Change or Addition | | 019697 | 003 | AP | 1994/06/28 | Labeling Revision | | 019697 | 002 | AP | 1995/02/16 | Control Supplement | | 019697 | 000 | AP | 1992/07/03 | Approval |
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