药品名称 | MICRONOR | 申请号 | 016954 | 产品号 | 001 | 活性成分 | NORETHINDRONE | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL-28 | 规格 | 0.35MG | 治疗等效代码 | AB2 | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 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 | 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 | 016954 | 106 | AP | Letter | 2014/06/19 | 下载 | 016954 | 106 | AP | Label | 2014/07/02 | 下载 | 016954 | 101 | AP | Letter | 2008/06/24 | 下载 | 016954 | 101 | AP | Label | 2008/06/26 | 下载 | 016954 | 092 | AP | Letter | 2003/10/09 | 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 | 016954 | 107 | AP | 2014/09/11 | Manufacturing Change or Addition | 016954 | 106 | AP | 2014/06/18 | Labeling Revision | 016954 | 101 | AP | 2008/06/20 | Labeling Revision | 016954 | 092 | AP | 2003/10/01 | Labeling Revision | 016954 | 091 | AP | 2002/06/20 | Manufacturing Change or Addition | 016954 | 090 | AP | 2000/05/24 | Control Supplement | 016954 | 089 | AP | 2000/05/23 | Control Supplement | 016954 | 088 | AP | 2000/01/05 | Package Change | 016954 | 087 | AP | 1998/04/28 | Manufacturing Change or Addition | 016954 | 086 | AP | 1998/04/13 | Manufacturing Change or Addition | 016954 | 085 | AP | 1999/11/10 | Labeling Revision | 016954 | 084 | AP | 1997/01/14 | Control Supplement | 016954 | 083 | AP | 1996/03/14 | Labeling Revision | 016954 | 082 | AP | 1996/04/09 | Control Supplement | 016954 | 081 | AP | 1995/11/30 | Manufacturing Change or Addition | 016954 | 080 | AP | 1995/09/07 | Control Supplement | 016954 | 079 | AP | 1994/06/28 | Labeling Revision | 016954 | 078 | AP | 1993/11/04 | Manufacturing Change or Addition | 016954 | 077 | AP | 1993/05/18 | Control Supplement | 016954 | 075 | AP | 1990/07/26 | Control Supplement | 016954 | 074 | AP | 1991/09/16 | Labeling Revision | 016954 | 073 | AP | 1990/01/18 | Control Supplement | 016954 | 072 | AP | 1989/10/23 | Labeling Revision | 016954 | 071 | AP | 1989/07/19 | Labeling Revision | 016954 | 070 | AP | 1988/10/28 | Control Supplement | 016954 | 069 | AP | 1988/09/09 | Labeling Revision | 016954 | 068 | AP | 1987/02/26 | Labeling Revision | 016954 | 067 | AP | 1987/11/23 | Control Supplement | 016954 | 065 | AP | 1985/10/21 | Labeling Revision | 016954 | 063 | AP | 1985/04/05 | Labeling Revision | 016954 | 062 | AP | 1984/06/21 | Control Supplement | 016954 | 061 | AP | 1984/01/30 | Labeling Revision | 016954 | 060 | AP | 1983/09/29 | Labeling Revision | 016954 | 059 | AP | 1983/06/15 | Labeling Revision | 016954 | 058 | AP | 1983/06/09 | Control Supplement | 016954 | 056 | AP | 1982/09/29 | Labeling Revision | 016954 | 053 | AP | 1980/11/20 | Control Supplement | 016954 | 051 | AP | 1980/08/21 | Manufacturing Change or Addition | 016954 | 050 | AP | 1980/03/24 | Manufacturing Change or Addition | 016954 | 049 | AP | 1979/11/08 | Control Supplement | 016954 | 047 | AP | 1979/08/15 | Labeling Revision | 016954 | 046 | AP | 1979/10/19 | Package Change | 016954 | 044 | AP | 1978/12/19 | Labeling Revision | 016954 | 039 | AP | 1979/06/21 | Other Amendment | 016954 | 036 | AP | 1978/09/25 | Package Change | 016954 | 033 | AP | 1978/04/17 | Control Supplement | 016954 | 032 | AP | 1978/05/25 | Control Supplement | 016954 | 028 | AP | 1978/03/29 | Control Supplement | 016954 | 019 | AP | 1976/05/18 | Control Supplement | 016954 | 018 | AP | 1976/05/18 | Control Supplement | 016954 | 017 | AP | 1976/05/18 | Control Supplement | 016954 | 015 | AP | 1975/08/07 | Control Supplement | 016954 | 014 | AP | 1975/08/07 | Control Supplement | 016954 | 013 | AP | 1975/08/07 | Control Supplement | 016954 | 012 | AP | 1975/08/07 | Control Supplement | 016954 | 011 | AP | 1975/08/07 | Control Supplement | 016954 | 010 | AP | 1975/08/07 | Control Supplement | 016954 | 009 | AP | 1975/05/21 | Control Supplement | 016954 | 008 | AP | 1975/05/21 | Control Supplement | 016954 | 007 | AP | 1975/05/21 | Control Supplement | 016954 | 006 | AP | 1975/05/21 | Other Amendment | 016954 | 005 | AP | 1975/03/06 | Other Amendment | 016954 | 000 | AP | 1973/01/02 | Approval |
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