| 药品名称 | ANAFRANIL | | 申请号 | 019906 | 产品号 | 003 | | 活性成分 | CLOMIPRAMINE HYDROCHLORIDE | 市场状态 | 处方药 | | 剂型或给药途径 | CAPSULE;ORAL | 规格 | 75MG | | 治疗等效代码 | AB | 参比药物 | 否 | | 批准日期 | 1989/12/29 | 申请机构 | MALLINCKRODT LLC
| | 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 | | 019906 | 039 | AP | Letter | 2014/07/29 | 下载 | | 019906 | 039 | AP | Label | 2014/07/29 | 下载 | | 019906 | 038 | AP | Label | 2014/07/11 | 下载 | | 019906 | 038 | AP | Letter | 2014/07/11 | 下载 | | 019906 | 037 | AP | Label | 2012/10/26 | 下载 | | 019906 | 037 | AP | Letter | 2012/10/29 | 下载 | | 019906 | 034 | AP | Label | 2007/07/16 | 下载 | | 019906 | 034 | AP | Letter | 2007/07/24 | 下载 | | 019906 | 032 | AP | Letter | 2005/01/13 | 下载 | | 019906 | 032 | AP | Label | 2005/01/13 | 下载 | | 019906 | 030 | AP | Letter | 2004/09/07 | 下载 | | 019906 | 022 | AP | Review | 2007/06/12 | 下载 | | 019906 | 009 | AP | Label | 2003/06/10 | 下载 | | 019906 | 000 | AP | Other Important Information from FDA | 2007/05/09 | 下载 | | 019906 | 000 | AP | Medication Guide | 2009/11/16 | 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 | | 019906 | 039 | AP | 2014/07/28 | Labeling Revision | | 019906 | 038 | AP | 2014/07/10 | Labeling Revision | | 019906 | 037 | AP | 2012/10/26 | Labeling Revision | | 019906 | 034 | AP | 2007/07/13 | Labeling Revision | | 019906 | 032 | AP | 2005/01/12 | Labeling Revision | | 019906 | 030 | AP | 2004/09/03 | Labeling Revision | | 019906 | 028 | AP | 2002/06/20 | Manufacturing Change or Addition | | 019906 | 027 | AP | 2001/03/23 | Control Supplement | | 019906 | 026 | AP | 2000/10/31 | Manufacturing Change or Addition | | 019906 | 025 | AP | 2000/07/03 | Manufacturing Change or Addition | | 019906 | 024 | AP | 1999/04/15 | Package Change | | 019906 | 023 | AP | 1999/03/08 | Manufacturing Change or Addition | | 019906 | 022 | AP | 1999/01/04 | Labeling Revision | | 019906 | 021 | AP | 1998/05/18 | Control Supplement | | 019906 | 020 | AP | 1998/01/15 | Labeling Revision | | 019906 | 019 | AP | 1997/04/02 | Labeling Revision | | 019906 | 018 | AP | 1997/02/11 | Control Supplement | | 019906 | 017 | AP | 1997/04/02 | Labeling Revision | | 019906 | 016 | AP | 1995/11/22 | Manufacturing Change or Addition | | 019906 | 015 | AP | 1995/12/14 | Control Supplement | | 019906 | 014 | AP | 1995/10/20 | Manufacturing Change or Addition | | 019906 | 013 | AP | 1995/10/05 | Control Supplement | | 019906 | 012 | AP | 1994/04/13 | Labeling Revision | | 019906 | 011 | AP | 1994/07/13 | Control Supplement | | 019906 | 010 | AP | 1994/07/01 | Control Supplement | | 019906 | 009 | AP | 2001/07/31 | Labeling Revision | | 019906 | 008 | AP | 1994/04/13 | Labeling Revision | | 019906 | 007 | AP | 1991/04/09 | Labeling Revision | | 019906 | 006 | AP | 1991/05/15 | Control Supplement | | 019906 | 005 | AP | 1991/04/09 | Labeling Revision | | 019906 | 004 | AP | 1991/01/31 | Formulation Revision | | 019906 | 001 | AP | 1991/04/09 | Labeling Revision | | 019906 | 000 | AP | 1989/12/29 | Approval |
|