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 |
2024/02/15 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/07/27 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/01 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/09/29 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/09/29 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/08/12 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/16 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2008/08/25 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/07/24 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/05/16 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/01/05 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/04/18 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/04/26 |
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)