药品名称 | PERMAX | 申请号 | 019385 | 产品号 | 002 | 活性成分 | PERGOLIDE MESYLATE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | EQ 0.25MG BASE | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | 1988/12/30 | 申请机构 | VALEANT PHARMACEUTICALS INTERNATIONAL
| 化学类型 | New molecular entity (NME) | 审评分类 | Priority review drug |
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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 | 019385 | 035 | AP | Letter | 2003/10/09 | 下载![](pdf.jpg) | 019385 | 035 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 019385 | 035 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019385 | 031 | AP | Review | 2009/01/12 | 下载![](pdf.jpg) | 019385 | 031 | AP | Letter | 2003/10/09 | 下载![](pdf.jpg) | 019385 | 031 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 019385 | 030 | AP | Label | 2003/10/10 | 下载![](pdf.jpg) | 019385 | 030 | AP | Letter | 2003/10/09 | 下载![](pdf.jpg) | 019385 | 028 | AP | Letter | 2002/08/29 | 下载![](pdf.jpg) | 019385 | 000 | AP | Other Important Information from FDA | 2007/03/29 | 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 | 019385 | 035 | AP | 2003/10/02 | Labeling Revision | 019385 | 032 | AP | 2002/05/17 | Control Supplement | 019385 | 031 | AP | 2003/10/02 | Labeling Revision | 019385 | 030 | AP | 2003/10/02 | Labeling Revision | 019385 | 029 | AP | 2000/12/07 | Control Supplement | 019385 | 028 | AP | 2002/08/29 | Labeling Revision | 019385 | 027 | AP | 1999/10/01 | Manufacturing Change or Addition | 019385 | 026 | AP | 1999/10/06 | Labeling Revision | 019385 | 025 | AP | 1999/04/13 | Manufacturing Change or Addition | 019385 | 024 | AP | 1998/06/26 | Manufacturing Change or Addition | 019385 | 022 | AP | 1998/04/13 | Manufacturing Change or Addition | 019385 | 021 | AP | 1998/04/03 | Package Change | 019385 | 020 | AP | 1999/10/06 | Labeling Revision | 019385 | 019 | AP | 1999/10/06 | Labeling Revision | 019385 | 017 | AP | 1999/10/06 | Labeling Revision | 019385 | 016 | AP | 1999/10/06 | Labeling Revision | 019385 | 014 | AP | 1994/11/29 | Formulation Revision | 019385 | 013 | AP | 1994/12/15 | Control Supplement | 019385 | 012 | AP | 1994/12/15 | Control Supplement | 019385 | 011 | AP | 1994/12/15 | Control Supplement | 019385 | 010 | AP | 1993/01/11 | Control Supplement | 019385 | 009 | AP | 1993/01/11 | Package Change | 019385 | 008 | AP | 1999/10/06 | Labeling Revision | 019385 | 007 | AP | 1993/01/08 | Package Change | 019385 | 006 | AP | 1991/05/15 | Control Supplement | 019385 | 005 | AP | 1993/01/08 | Manufacturing Change or Addition | 019385 | 004 | AP | 1999/10/06 | Labeling Revision | 019385 | 003 | AP | 1989/11/27 | Manufacturing Change or Addition | 019385 | 002 | AP | 1989/11/02 | Labeling Revision | 019385 | 001 | AP | 1989/03/17 | Control Supplement | 019385 | 000 | AP | 1988/12/30 | Approval |
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