药品名称 | PREMARIN | 申请号 | 004782 | 产品号 | 005 | 活性成分 | ESTROGENS, CONJUGATED | 市场状态 | 处方药 | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.9MG | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 1984/01/26 | 申请机构 | WYETH PHARMACEUTICALS INC
| 化学类型 | New molecular entity (NME) | 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 | 004782 | 171 | AP | Letter | 2014/12/04 | 下载 | 004782 | 171 | AP | Label | 2014/12/10 | 下载 | 004782 | 167 | AP | Label | 2011/11/01 | 下载 | 004782 | 167 | AP | Letter | 2011/10/31 | 下载 | 004782 | 164 | AP | Letter | 2011/10/31 | 下载 | 004782 | 164 | AP | Label | 2011/11/01 | 下载 | 004782 | 162 | AP | Letter | 2011/10/31 | 下载 | 004782 | 162 | AP | Label | 2011/11/01 | 下载 | 004782 | 155 | AP | Label | 2008/03/05 | 下载 | 004782 | 155 | AP | Letter | 2008/03/05 | 下载 | 004782 | 147 | AP | Label | 2006/09/12 | 下载 | 004782 | 147 | AP | Letter | 2006/09/18 | 下载 | 004782 | 146 | AP | Label | 2006/04/25 | 下载 | 004782 | 146 | AP | Letter | 2006/04/25 | 下载 | 004782 | 142 | AP | Letter | 2005/11/03 | 下载 | 004782 | 142 | AP | Label | 2005/11/03 | 下载 | 004782 | 141 | AP | Label | 2005/08/04 | 下载 | 004782 | 141 | AP | Letter | 2005/08/04 | 下载 | 004782 | 139 | AP | Label | 2005/04/12 | 下载 | 004782 | 139 | AP | Letter | 2005/04/12 | 下载 | 004782 | 138 | AP | Label | 2005/04/12 | 下载 | 004782 | 138 | AP | Letter | 2005/04/12 | 下载 | 004782 | 137 | AP | Letter | 2004/08/31 | 下载 | 004782 | 137 | AP | Label | 2004/08/31 | 下载 | 004782 | 136 | AP | Label | 2004/11/17 | 下载 | 004782 | 136 | AP | Letter | 2004/04/29 | 下载 | 004782 | 133 | AP | Letter | 2004/04/29 | 下载 | 004782 | 133 | AP | Label | 2004/05/04 | 下载 | 004782 | 130 | AP | Label | 2003/04/30 | 下载 | 004782 | 130 | AP | Letter | 2003/05/16 | 下载 | 004782 | 130 | AP | Review | 2007/04/09 | 下载 | 004782 | 129 | AP | Letter | 2003/01/07 | 下载 | 004782 | 129 | AP | Label | 2003/01/07 | 下载 | 004782 | 128 | AP | Letter | 2002/11/27 | 下载 | 004782 | 128 | AP | Label | 2002/11/27 | 下载 | 004782 | 125 | AP | Letter | 2003/07/28 | 下载 | 004782 | 115 | AP | Letter | 2003/05/16 | 下载 | 004782 | 115 | AP | Label | 2003/04/28 | 下载 | 004782 | 115 | AP | Review | 2007/04/09 | 下载 | 004782 | 093 | AP | Review | 1998/09/08 | 下载 | 004782 | 093 | AP | Letter | 1998/09/08 | 下载 | 004782 | 000 | AP | Other Important Information from FDA | 2009/06/02 | 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 | 004782 | 173 | AP | 2015/09/01 | Manufacturing Change or Addition | 004782 | 172 | AP | 2015/06/09 | Manufacturing Change or Addition | 004782 | 171 | AP | 2014/12/03 | Labeling Revision | 004782 | 167 | AP | 2011/10/28 | Labeling Revision | 004782 | 164 | AP | 2011/10/28 | Labeling Revision | 004782 | 163 | AP | 2014/04/11 | Manufacturing Change or Addition | 004782 | 162 | AP | 2011/10/28 | Labeling Revision | 004782 | 155 | AP | 2008/03/03 | Labeling Revision | 004782 | 147 | AP | 2006/09/05 | Labeling Revision | 004782 | 146 | AP | 2006/04/24 | Labeling Revision | 004782 | 142 | AP | 2005/11/01 | Formulation Revision | 004782 | 141 | AP | 2005/08/01 | Formulation Revision | 004782 | 139 | AP | 2005/04/07 | Labeling Revision | 004782 | 138 | AP | 2005/04/07 | Labeling Revision | 004782 | 137 | AP | 2004/08/26 | Formulation Revision | 004782 | 136 | AP | 2004/04/20 | Labeling Revision | 004782 | 133 | AP | 2004/04/20 | Labeling Revision | 004782 | 130 | AP | 2003/04/24 | Labeling Revision | 004782 | 129 | AP | 2003/01/07 | Labeling Revision | 004782 | 128 | AP | 2002/11/27 | Labeling Revision | 004782 | 126 | AP | 2002/12/20 | Control Supplement | 004782 | 125 | AP | 2003/07/16 | Labeling Revision | 004782 | 124 | AP | 2002/08/21 | Control Supplement | 004782 | 121 | AP | 2001/12/03 | Control Supplement | 004782 | 120 | AP | 2001/08/06 | Control Supplement | 004782 | 116 | AP | 2001/04/24 | Expiration Date Change | 004782 | 115 | AP | 2003/04/24 | New Dosage Regimen | 004782 | 113 | AP | 2000/07/05 | Control Supplement | 004782 | 109 | AP | 1999/06/08 | Labeling Revision | 004782 | 108 | AP | 1998/10/29 | Control Supplement | 004782 | 104 | AP | 1998/05/06 | Labeling Revision | 004782 | 103 | AP | 1996/06/28 | Control Supplement | 004782 | 102 | AP | 1996/06/27 | Control Supplement | 004782 | 101 | AP | 1998/02/27 | Control Supplement | 004782 | 100 | AP | 1995/12/14 | Control Supplement | 004782 | 099 | AP | 1995/12/13 | Control Supplement | 004782 | 098 | AP | 1995/04/11 | Control Supplement | 004782 | 096 | AP | 1998/05/06 | Labeling Revision | 004782 | 095 | AP | 1995/02/06 | Manufacturing Change or Addition | 004782 | 094 | AP | 1994/11/09 | Control Supplement | 004782 | 093 | AP | 1998/09/08 | New Dosage Regimen | 004782 | 092 | AP | 1993/12/23 | Labeling Revision | 004782 | 087 | AP | 1992/03/11 | Package Change | 004782 | 086 | AP | 1999/04/26 | Control Supplement | 004782 | 083 | AP | 1990/02/23 | Formulation Revision | 004782 | 081 | AP | 1989/12/22 | Labeling Revision | 004782 | 079 | AP | 1989/05/19 | Labeling Revision | 004782 | 078 | AP | 1991/05/09 | Expiration Date Change | 004782 | 077 | AP | 1991/05/14 | Control Supplement | 004782 | 075 | AP | 1989/05/19 | Labeling Revision | 004782 | 074 | AP | 1989/02/03 | Formulation Revision | 004782 | 073 | AP | 1988/12/20 | Package Change | 004782 | 072 | AP | 1989/05/19 | Labeling Revision | 004782 | 071 | AP | 1988/04/17 | Control Supplement | 004782 | 070 | AP | 1987/05/14 | Manufacturing Change or Addition | 004782 | 068 | AP | 1987/10/16 | Control Supplement | 004782 | 066 | AP | 1986/09/24 | Manufacturing Change or Addition | 004782 | 065 | AP | 1986/12/03 | Control Supplement | 004782 | 064 | AP | 1989/05/19 | Labeling Revision | 004782 | 063 | AP | 1986/07/10 | Control Supplement | 004782 | 062 | AP | 1986/05/12 | Control Supplement | 004782 | 061 | AP | 1989/05/19 | Labeling Revision | 004782 | 060 | AP | 1986/01/07 | Formulation Revision | 004782 | 059 | AP | 1985/10/25 | Package Change | 004782 | 058 | AP | 1985/09/30 | Control Supplement | 004782 | 057 | AP | 1986/05/28 | Labeling Revision | 004782 | 054 | AP | 1985/04/29 | Labeling Revision | 004782 | 053 | AP | 1985/04/29 | Labeling Revision | 004782 | 052 | AP | 1985/05/29 | Control Supplement | 004782 | 051 | AP | 1985/04/29 | Labeling Revision | 004782 | 050 | AP | 1985/05/29 | Package Change | 004782 | 049 | AP | 1984/01/26 | Formulation Revision | 004782 | 000 | AP | 1942/05/08 | Approval |
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