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 |
2023/02/15 |
SUPPL-129(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2022/11/23 |
SUPPL-130(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/05/27 |
SUPPL-122(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/05/11 |
SUPPL-124(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/02/25 |
SUPPL-127(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/02/25 |
SUPPL-126(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2021/05/25 |
SUPPL-121(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/11/13 |
SUPPL-119(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/10/02 |
SUPPL-115(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/09/18 |
SUPPL-112(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/08/13 |
SUPPL-111(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/06/29 |
SUPPL-106(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/05/26 |
SUPPL-110(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/05/15 |
SUPPL-109(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/03/10 |
SUPPL-108(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/09/20 |
SUPPL-104(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/05/08 |
SUPPL-102(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/07/10 |
SUPPL-96(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/04/16 |
SUPPL-94(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/02/08 |
SUPPL-93(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/12/13 |
SUPPL-91(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/10/20 |
SUPPL-86(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2017/07/21 |
SUPPL-87(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2017/03/03 |
SUPPL-84(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/10/28 |
SUPPL-73(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2015/08/17 |
SUPPL-74(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/03/19 |
SUPPL-72(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/03/16 |
SUPPL-71(补充) |
Approval |
REMS |
N/A
|
|
|
2013/12/05 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/05/22 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/10/26 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/16 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/07/28 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/25 |
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 |