药品名称 | MODICON 21 | 申请号 | 017488 | 产品号 | 001 | 活性成分 | ETHINYL ESTRADIOL; NORETHINDRONE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL-21 | 规格 | 0.035MG;0.5MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ORTHO MCNEIL PHARMACEUTICAL 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 | 无 |
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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 | 017488 | 108 | AP | 2002/02/21 | Manufacturing Change or Addition | 017488 | 107 | AP | 2001/07/09 | Control Supplement | 017488 | 105 | AP | 2000/01/05 | Package Change | 017488 | 104 | AP | 1999/08/27 | Labeling Revision | 017488 | 103 | AP | 1998/04/28 | Manufacturing Change or Addition | 017488 | 102 | AP | 1998/04/13 | Manufacturing Change or Addition | 017488 | 101 | AP | 1999/08/27 | Labeling Revision | 017488 | 100 | AP | 1997/02/24 | Control Supplement | 017488 | 099 | AP | 1997/01/29 | Control Supplement | 017488 | 098 | AP | 1996/04/09 | Control Supplement | 017488 | 097 | AP | 1996/05/10 | Control Supplement | 017488 | 096 | AP | 1995/11/30 | Manufacturing Change or Addition | 017488 | 095 | AP | 1995/09/07 | Control Supplement | 017488 | 094 | AP | 1995/02/16 | Control Supplement | 017488 | 093 | AP | 1994/06/28 | Labeling Revision | 017488 | 092 | AP | 1993/11/04 | Manufacturing Change or Addition | 017488 | 091 | AP | 1993/05/18 | Control Supplement | 017488 | 090 | AP | 1994/03/07 | Formulation Revision | 017488 | 088 | AP | 1991/03/18 | Control Supplement | 017488 | 087 | AP | 1991/09/16 | Labeling Revision | 017488 | 085 | AP | 1989/10/23 | Labeling Revision | 017488 | 084 | AP | 1989/07/19 | Labeling Revision | 017488 | 083 | AP | 1988/10/28 | Control Supplement | 017488 | 082 | AP | 1988/06/08 | Manufacturing Change or Addition | 017488 | 081 | AP | 1988/09/09 | Labeling Revision | 017488 | 080 | AP | 1987/02/26 | Labeling Revision | 017488 | 079 | AP | 1987/11/23 | Control Supplement | 017488 | 077 | AP | 1985/10/21 | Labeling Revision | 017488 | 076 | AP | 1985/04/05 | Labeling Revision | 017488 | 075 | AP | 1984/06/21 | Labeling Revision | 017488 | 074 | AP | 1984/01/30 | Labeling Revision | 017488 | 073 | AP | 1983/09/29 | Labeling Revision | 017488 | 071 | AP | 1983/06/15 | Labeling Revision | 017488 | 070 | AP | 1983/06/09 | Control Supplement | 017488 | 069 | AP | 1980/11/20 | Control Supplement | 017488 | 068 | AP | 1980/11/20 | Control Supplement | 017488 | 066 | AP | 1980/08/21 | Control Supplement | 017488 | 065 | AP | 1980/03/28 | Expiration Date Change | 017488 | 064 | AP | 1980/03/24 | Manufacturing Change or Addition | 017488 | 063 | AP | 1979/11/13 | Labeling Revision | 017488 | 062 | AP | 1979/08/15 | Labeling Revision | 017488 | 060 | AP | 1979/05/07 | Expiration Date Change | 017488 | 059 | AP | 1979/08/15 | Labeling Revision | 017488 | 058 | AP | 1979/10/19 | Package Change | 017488 | 054 | AP | 1978/06/01 | Labeling Revision | 017488 | 045 | AP | 1979/06/19 | Formulation Revision | 017488 | 042 | AP | 1978/04/17 | Control Supplement | 017488 | 041 | AP | 1978/05/25 | Control Supplement | 017488 | 037 | AP | 1977/10/20 | Control Supplement | 017488 | 036 | AP | 1978/03/29 | Control Supplement | 017488 | 035 | AP | 1978/01/18 | Package Change | 017488 | 034 | AP | 1978/01/18 | Package Change | 017488 | 033 | AP | 1978/01/18 | Labeling Revision | 017488 | 032 | AP | 1978/01/18 | Labeling Revision | 017488 | 031 | AP | 1978/07/31 | Control Supplement | 017488 | 025 | AP | 1977/07/01 | Labeling Revision | 017488 | 024 | AP | 1976/12/23 | Control Supplement | 017488 | 022 | AP | 1976/05/11 | Control Supplement | 017488 | 021 | AP | 1976/05/11 | Package Change | 017488 | 012 | AP | 1976/05/18 | Control Supplement | 017488 | 010 | AP | 1976/05/18 | Control Supplement | 017488 | 009 | AP | 1976/05/18 | Control Supplement | 017488 | 008 | AP | 1976/05/18 | Control Supplement | 017488 | 006 | AP | 1975/08/07 | Control Supplement | 017488 | 005 | AP | 1975/08/07 | Control Supplement | 017488 | 004 | AP | 1975/08/07 | Control Supplement | 017488 | 003 | AP | 1975/08/07 | Control Supplement | 017488 | 002 | AP | 1975/08/07 | Control Supplement | 017488 | 001 | AP | 1975/08/07 | Control Supplement | 017488 | 000 | AP | 1974/10/15 | Approval |
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