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 |
2023/02/08 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/03/01 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/08/23 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/01/28 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/03/10 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/11/15 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/10/11 |
SUPPL-33(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2019/08/23 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/15 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/15 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/11/07 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/07/30 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/10/27 |
SUPPL-24(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/06/28 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/10 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/25 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/25 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/17 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/10/26 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/05 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/02/16 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/01/15 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/12/19 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/09/15 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/03/06 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/02/13 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/07 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/01 |
SUPPL-4(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2013/01/31 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/11/02 |
SUPPL-3(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2012/11/02 |
SUPPL-2(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2012/11/02 |
SUPPL-1(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2011/07/01 |
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)