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 |
2023/09/07 |
SUPPL-36(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2022/07/14 |
SUPPL-33(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2021/09/22 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2021/01/14 |
SUPPL-30(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/06/25 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/12/06 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/11/30 |
SUPPL-26(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2018/02/07 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/02/07 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2017/07/21 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/04/28 |
SUPPL-19(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2017/01/24 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/04/29 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/04/28 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2016/03/11 |
SUPPL-16(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2015/12/07 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/09/14 |
SUPPL-14(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2015/03/20 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/08/26 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/05/28 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/02/14 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/11/20 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2013/10/07 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/10/07 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/09/13 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/03/12 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/02/28 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/24 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/02/17 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/08/26 |
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)