药品名称 | MINIPRESS | 申请号 | 017442 | 产品号 | 003 | 活性成分 | PRAZOSIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 2MG BASE | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | PFIZER LABORATORIES DIV PFIZER INC
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
|
|
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 |
|
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 |
|
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 | 017442 | 043 | AP | Label | 2015/03/02 | 下载 | 017442 | 043 | AP | Letter | 2015/03/02 | 下载 | 017442 | 041 | AP | Label | 2013/11/04 | 下载 | 017442 | 041 | AP | Letter | 2013/11/07 | 下载 | 017442 | 035 | AP | Letter | 2009/07/15 | 下载 | 017442 | 035 | AP | Label | 2009/07/23 | 下载 | 017442 | 033 | AP | Letter | 2009/04/09 | 下载 | 017442 | 033 | AP | Label | 2009/04/16 | 下载 | 017442 | 029 | AP | Letter | 2001/06/12 | 下载 |
|
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 | 017442 | 044 | AP | 2016/01/08 | Manufacturing Change or Addition | 017442 | 043 | AP | 2015/02/27 | Labeling Revision | 017442 | 042 | AP | 2014/07/28 | Manufacturing Change or Addition | 017442 | 041 | AP | 2013/11/04 | Labeling Revision | 017442 | 035 | AP | 2009/07/10 | Labeling Revision | 017442 | 033 | AP | 2009/04/06 | Labeling Revision | 017442 | 029 | AP | 2001/06/12 | Labeling Revision | 017442 | 028 | AP | 1994/05/10 | Manufacturing Change or Addition | 017442 | 027 | AP | 1989/05/01 | Labeling Revision | 017442 | 026 | AP | 1989/08/21 | Manufacturing Change or Addition | 017442 | 025 | AP | 1988/10/14 | Manufacturing Change or Addition | 017442 | 024 | AP | 1988/08/29 | Package Change | 017442 | 023 | AP | 1987/07/14 | Manufacturing Change or Addition | 017442 | 022 | AP | 1988/06/06 | Control Supplement | 017442 | 021 | AP | 1985/09/27 | Control Supplement | 017442 | 020 | AP | 1986/04/25 | Labeling Revision | 017442 | 019 | AP | 1985/02/26 | Labeling Revision | 017442 | 018 | AP | 1984/08/13 | Labeling Revision | 017442 | 017 | AP | 1984/09/13 | Package Change | 017442 | 016 | AP | 1984/08/03 | Package Change | 017442 | 015 | AP | 1984/08/01 | Package Change | 017442 | 014 | AP | 1983/11/29 | Control Supplement | 017442 | 013 | AP | 1986/04/25 | Practioner Draft Labeling | 017442 | 012 | AP | 1982/02/19 | Labeling Revision | 017442 | 011 | AP | 1982/02/19 | Manufacturing Change or Addition | 017442 | 010 | AP | 1981/11/17 | Control Supplement | 017442 | 009 | AP | 1981/09/25 | Package Change | 017442 | 008 | AP | 1981/07/30 | Package Change | 017442 | 007 | AP | 1981/01/14 | Labeling Revision | 017442 | 005 | AP | 1979/01/10 | Labeling Revision | 017442 | 004 | AP | 1982/08/06 | Package Change | 017442 | 003 | AP | 1978/11/27 | Formulation Revision | 017442 | 002 | AP | 1977/06/14 | Labeling Revision | 017442 | 001 | AP | 1977/07/13 | Control Supplement | 017442 | 000 | AP | 1976/06/23 | Approval |
|