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 |
2019/04/02 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/11 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/04/02 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/10/16 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/07/10 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/09 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/08 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/23 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/01/05 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/02/14 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/11/07 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/09/06 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/03/07 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/08/21 |
SUPPL-3(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2008/06/25 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/28 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)