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 |
2023/11/15 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/23 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/04/05 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/02 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2015/05/21 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/08/21 |
SUPPL-8(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/10/13 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/09/01 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/28 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/04/27 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)