药品名称 | DDAVP (NEEDS NO REFRIGERATION) | 申请号 | 017922 | 产品号 | 003 | 活性成分 | DESMOPRESSIN ACETATE | 市场状态 | 处方药 | 剂型或给药途径 | SPRAY, METERED;NASAL | 规格 | 0.01MG/SPRAY | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1996/08/07 | 申请机构 | FERRING PHARMACEUTICALS INC
| 化学类型 | New molecular entity (NME) | 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 | 017922 | 042 | AP | Letter | 2015/11/09 | 下载 | 017922 | 042 | AP | Label | 2015/11/19 | 下载 | 017922 | 038 | AP | Label | 2007/11/07 | 下载 | 017922 | 038 | AP | Letter | 2007/11/08 | 下载 | 017922 | 034 | AP | Label | 2005/11/16 | 下载 | 017922 | 034 | AP | Letter | 2005/11/17 | 下载 | 017922 | 031 | AP | Letter | 2003/11/25 | 下载 | 017922 | 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 | 017922 | 044 | AP | 2015/07/31 | Manufacturing Change or Addition | 017922 | 043 | AP | 2014/02/28 | Manufacturing Change or Addition | 017922 | 042 | AP | 2015/11/05 | Labeling Revision | 017922 | 039 | AP | 2007/10/26 | Labeling Revision | 017922 | 038 | AP | 2007/10/26 | Labeling Revision | 017922 | 034 | AP | 2005/11/10 | Labeling Revision | 017922 | 031 | AP | 2003/11/12 | Labeling Revision | 017922 | 029 | AP | 2001/02/28 | Control Supplement | 017922 | 028 | AP | 2000/10/31 | Control Supplement | 017922 | 027 | AP | 2000/07/05 | Control Supplement | 017922 | 026 | AP | 1999/09/24 | Control Supplement | 017922 | 025 | AP | 1998/04/13 | Labeling Revision | 017922 | 024 | AP | 1996/01/16 | Labeling Revision | 017922 | 023 | AP | 1996/08/07 | Formulation Revision | 017922 | 022 | AP | 1995/01/26 | Control Supplement | 017922 | 021 | AP | 1991/09/27 | Labeling Revision | 017922 | 020 | AP | 1992/04/22 | Manufacturing Change or Addition | 017922 | 019 | AP | 1990/08/23 | Labeling Revision | 017922 | 018 | AP | 1989/07/19 | Labeling Revision | 017922 | 017 | AP | 1989/06/23 | Package Change | 017922 | 015 | AP | 1988/05/25 | Manufacturing Change or Addition | 017922 | 014 | AP | 1988/06/29 | Control Supplement | 017922 | 013 | AP | 1989/02/06 | Package Change | 017922 | 012 | AP | 1989/11/28 | New or Modified Indication | 017922 | 011 | AP | 1985/11/07 | Labeling Revision | 017922 | 010 | AP | 1984/11/27 | Labeling Revision | 017922 | 009 | AP | 1984/06/01 | Package Change | 017922 | 007 | AP | 1983/01/21 | Labeling Revision | 017922 | 006 | AP | 1983/03/24 | Labeling Revision | 017922 | 005 | AP | 1982/08/27 | Control Supplement | 017922 | 004 | AP | 1982/06/08 | Labeling Revision | 017922 | 002 | AP | 1981/05/21 | Package Change | 017922 | 001 | AP | 1980/02/28 | Manufacturing Change or Addition | 017922 | 000 | AP | 1978/02/21 | Approval |
|