批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级;罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
2021/12/17 |
SUPPL-5467(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/12/02 |
SUPPL-5465(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2021/06/30 |
SUPPL-5464(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/08/28 |
SUPPL-5460(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/03/13 |
SUPPL-5458(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/01/23 |
SUPPL-5461(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/11/25 |
SUPPL-5459(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/09/27 |
SUPPL-5457(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/01/25 |
SUPPL-5454(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2018/10/18 |
SUPPL-5451(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2018/06/07 |
SUPPL-5450(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/04/03 |
SUPPL-5453(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/08/12 |
SUPPL-5432(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/09/24 |
SUPPL-5414(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/09 |
SUPPL-5409(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/10/19 |
SUPPL-5388(补充) |
Approval |
Labeling |
|
|
|
2012/10/19 |
SUPPL-5367(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2012/07/13 |
SUPPL-5373(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/13 |
SUPPL-5370(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/17 |
SUPPL-5362(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/19 |
SUPPL-5344(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2011/01/28 |
SUPPL-5332(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2011/01/06 |
SUPPL-5343(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/10/06 |
SUPPL-5334(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/02/18 |
SUPPL-5312(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2010/02/18 |
SUPPL-5311(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2009/10/16 |
SUPPL-5299(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2009/09/22 |
SUPPL-5310(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/09/08 |
SUPPL-5291(补充) |
Approval |
Supplement |
|
|
|
2008/09/08 |
SUPPL-5285(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/25 |
SUPPL-5256(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2008/01/24 |
SUPPL-5263(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/09/28 |
SUPPL-5262(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/08/22 |
SUPPL-5259(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/02/21 |
SUPPL-5247(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/09/29 |
SUPPL-5231(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2006/09/29 |
SUPPL-5230(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2006/02/28 |
SUPPL-5211(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2006/02/10 |
SUPPL-5209(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
1997/11/26 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |