| 药品名称 | DDAVP | | 申请号 | 018938 | 产品号 | 002 | | 活性成分 | DESMOPRESSIN ACETATE | 市场状态 | 停止上市 | | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 0.015MG/ML | | 治疗等效代码 | | 参比药物 | 否 | | 批准日期 | 1995/04/25 | 申请机构 | FERRING PHARMACEUTICALS INC
| | 化学类型 | New dosage form | 审评分类 | Priority review drug |
|
|
|
| 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 | | 018938 | 029 | AP | Letter | 2015/11/09 | 下载 | | 018938 | 029 | AP | Label | 2015/11/19 | 下载 | | 018938 | 027 | AP | Label | 2007/11/07 | 下载 | | 018938 | 027 | AP | Letter | 2007/11/08 | 下载 | | 018938 | 023 | AP | Label | 2005/11/16 | 下载 | | 018938 | 023 | AP | Letter | 2005/11/17 | 下载 | | 018938 | 019 | AP | Letter | 2003/11/25 | 下载 | | 018938 | 017 | AP | Letter | 2002/08/08 | 下载 | | 018938 | 017 | AP | Review | 2007/07/09 | 下载 | | 018938 | 000 | AP | Other Important Information from FDA | 2007/12/04 | 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 | | 018938 | 034 | AP | 2015/12/18 | Manufacturing Change or Addition | | 018938 | 033 | AP | 2015/04/22 | Manufacturing Change or Addition | | 018938 | 032 | AP | 2014/06/10 | Manufacturing Change or Addition | | 018938 | 031 | AP | 2014/02/28 | Manufacturing Change or Addition | | 018938 | 030 | AP | 2013/11/13 | Manufacturing Change or Addition | | 018938 | 029 | AP | 2015/11/05 | Labeling Revision | | 018938 | 027 | AP | 2007/10/26 | Labeling Revision | | 018938 | 023 | AP | 2005/11/10 | Labeling Revision | | 018938 | 019 | AP | 2003/11/12 | Labeling Revision | | 018938 | 017 | AP | 2002/08/08 | Labeling Revision | | 018938 | 016 | AP | 2000/10/31 | Control Supplement | | 018938 | 015 | AP | 2000/01/13 | Manufacturing Change or Addition | | 018938 | 014 | AP | 1999/09/24 | Control Supplement | | 018938 | 013 | AP | 1998/08/17 | Labeling Revision | | 018938 | 011 | AP | 1995/04/25 | Control Supplement | | 018938 | 010 | AP | 1995/03/13 | Labeling Revision | | 018938 | 009 | AP | 1994/01/11 | Labeling Revision | | 018938 | 008 | AP | 1993/05/12 | Labeling Revision | | 018938 | 007 | AP | 1992/04/22 | Manufacturing Change or Addition | | 018938 | 006 | AP | 1991/01/03 | Control Supplement | | 018938 | 005 | AP | 1990/04/03 | Labeling Revision | | 018938 | 004 | AP | 1988/07/01 | Control Supplement | | 018938 | 003 | AP | 1988/05/25 | Manufacturing Change or Addition | | 018938 | 002 | AP | 1985/11/07 | Labeling Revision | | 018938 | 001 | AP | 1984/12/20 | Labeling Revision | | 018938 | 000 | AP | 1984/03/30 | Approval |
|