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 |
2023/08/28 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/01/27 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/09/29 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/09 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
Letter and Label for PROAIR DIGIHALER |
2016/09/08 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
Letter and Label for PROAIR RESPICLICK |
2016/05/11 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/04/28 |
SUPPL-4(补充) |
Approval |
Efficacy |
STANDARD
|
|
Letter and Label for PROAIR RESPICLICK |
2015/12/11 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/07/30 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/07/30 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/03/31 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
Label for PROAIR RESPICLICK |
与本品相关的专利信息(来自FDA橙皮书Orange Book)