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 |
2021/05/12 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/11/26 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/01/23 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/06/21 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/06/13 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/05/01 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/02/10 |
SUPPL-1(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2013/11/22 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/10/26 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)