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 |
2024/04/18 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2024/04/05 |
SUPPL-19(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2024/04/05 |
SUPPL-18(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/11/03 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2023/01/25 |
SUPPL-14(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/10/07 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/01/20 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/01/20 |
SUPPL-12(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/03/23 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/03/01 |
SUPPL-10(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/08/06 |
SUPPL-7(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/08/06 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/03/24 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/10/24 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/08 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
PRIORITY
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)