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 |
2021/12/09 |
SUPPL-7(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2019/12/11 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/06/28 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/09 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/14 |
SUPPL-2(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2017/01/10 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/01/28 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity and Type 4 - New Combination |
PRIORITY
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)