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 |
2024/01/19 |
SUPPL-249(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2023/10/30 |
SUPPL-250(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2022/04/13 |
SUPPL-235(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/12/15 |
SUPPL-240(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2020/06/17 |
SUPPL-225(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/06/17 |
SUPPL-199(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/06/17 |
SUPPL-194(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/03/21 |
SUPPL-224(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/06/30 |
SUPPL-209(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2017/03/30 |
SUPPL-211(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2016/06/07 |
SUPPL-200(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/12/30 |
SUPPL-179(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/12/20 |
SUPPL-171(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2012/02/17 |
SUPPL-138(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/08/18 |
SUPPL-131(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/07/29 |
SUPPL-122(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/06/23 |
SUPPL-107(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2009/08/25 |
SUPPL-86(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2008/04/07 |
SUPPL-45(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2008/03/21 |
SUPPL-59(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/03/13 |
SUPPL-16(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2006/12/12 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/12/23 |
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 |