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 |
2023/08/18 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/12/23 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/09/20 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/12/19 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/30 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/09/06 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/17 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/21 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/01/29 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/11/25 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/10/30 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/10/30 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/25 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/12/06 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/10/30 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/11/08 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/26 |
SUPPL-10(补充) |
Approval |
REMS |
N/A
|
|
|
2010/06/01 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2010/05/17 |
SUPPL-6(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/02/02 |
SUPPL-4(补充) |
Approval |
REMS |
UNKNOWN
|
|
|
2010/02/01 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/04/16 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2009/01/14 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)