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 |
2023/07/12 |
SUPPL-111(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/11/02 |
SUPPL-128(补充) |
Approval |
REMS |
N/A
|
|
|
2022/08/01 |
SUPPL-129(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/06/09 |
SUPPL-127(补充) |
Approval |
REMS |
N/A
|
|
|
2022/01/11 |
SUPPL-121(补充) |
Approval |
REMS |
N/A
|
|
|
2021/08/19 |
SUPPL-117(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2021/04/13 |
SUPPL-112(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/09/26 |
SUPPL-110(补充) |
Approval |
REMS |
N/A
;Orphan
|
|
|
2018/06/06 |
SUPPL-109(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/11/28 |
SUPPL-101(补充) |
Approval |
REMS |
N/A
|
|
|
2016/11/28 |
SUPPL-100(补充) |
Approval |
REMS |
N/A
|
|
|
2016/09/19 |
SUPPL-102(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2015/05/15 |
SUPPL-88(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2015/05/15 |
SUPPL-87(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2015/05/15 |
SUPPL-85(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/10/20 |
SUPPL-84(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2013/12/06 |
SUPPL-61(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2012/02/24 |
SUPPL-40(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/02/02 |
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 |