| 药品名称 | ASENDIN | | 申请号 | 018021 | 产品号 | 004 | | 活性成分 | AMOXAPINE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 150MG | | 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 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
| | 化学类型 | New molecular entity (NME) | 审评分类 | Standard 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 | | 018021 | 000 | AP | Other Important Information from FDA | 2007/05/09 | 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 | | 018021 | 041 | AP | 2001/09/25 | Labeling Revision | | 018021 | 040 | AP | 1999/03/04 | Control Supplement | | 018021 | 038 | AP | 1999/03/05 | Manufacturing Change or Addition | | 018021 | 037 | AP | 2000/04/06 | Labeling Revision | | 018021 | 036 | AP | 1997/05/14 | Control Supplement | | 018021 | 035 | AP | 1997/02/06 | Manufacturing Change or Addition | | 018021 | 034 | AP | 1996/08/29 | Control Supplement | | 018021 | 033 | AP | 2000/04/06 | Labeling Revision | | 018021 | 032 | AP | 1995/05/03 | Control Supplement | | 018021 | 031 | AP | 1994/03/29 | Manufacturing Change or Addition | | 018021 | 030 | AP | 1991/01/03 | Control Supplement | | 018021 | 028 | AP | 2000/04/06 | Labeling Revision | | 018021 | 027 | AP | 1988/02/18 | Labeling Revision | | 018021 | 026 | AP | 1987/07/30 | Labeling Revision | | 018021 | 025 | AP | 1987/06/04 | Control Supplement | | 018021 | 024 | AP | 1988/02/18 | Labeling Revision | | 018021 | 023 | AP | 1986/10/20 | Control Supplement | | 018021 | 022 | AP | 1988/02/18 | Labeling Revision | | 018021 | 021 | AP | 1988/02/18 | Other Amendment | | 018021 | 019 | AP | 1985/06/06 | Labeling Revision | | 018021 | 018 | AP | 1985/02/26 | Manufacturing Change or Addition | | 018021 | 017 | AP | 1984/12/13 | Formulation Revision | | 018021 | 016 | AP | 2000/04/06 | Labeling Revision | | 018021 | 014 | AP | 1983/08/23 | Control Supplement | | 018021 | 013 | AP | 1983/01/25 | Labeling Revision | | 018021 | 012 | AP | 1982/10/04 | Labeling Revision | | 018021 | 011 | AP | 1983/05/04 | Control Supplement | | 018021 | 010 | AP | 1982/05/18 | Manufacturing Change or Addition | | 018021 | 009 | AP | 1982/01/12 | Labeling Revision | | 018021 | 007 | AP | 1981/12/22 | Package Change | | 018021 | 006 | AP | 1981/06/22 | Package Change | | 018021 | 005 | AP | 1981/06/22 | Labeling Revision | | 018021 | 004 | AP | 1981/02/17 | Manufacturing Change or Addition | | 018021 | 003 | AP | 1981/04/13 | Manufacturing Change or Addition | | 018021 | 002 | AP | 1981/02/09 | Expiration Date Change | | 018021 | 001 | AP | 1981/02/09 | Package Change | | 018021 | 000 | AP | 1980/09/22 | Approval |
|