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 |
2022/12/21 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/06/10 |
SUPPL-47(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2022/06/10 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/04 |
SUPPL-45(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/06/17 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/02/28 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/12/20 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/02/25 |
SUPPL-40(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2014/11/24 |
SUPPL-36(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/08/12 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/04 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/06/04 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/04/23 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/01/30 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/10/19 |
SUPPL-30(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/10/19 |
SUPPL-29(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/08/05 |
SUPPL-31(补充) |
Approval |
REMS |
N/A
|
|
|
2010/11/12 |
SUPPL-28(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/08/13 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/10/30 |
SUPPL-25(补充) |
Approval |
REMS |
UNKNOWN
|
|
|
2009/10/30 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/30 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/30 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/30 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/10/30 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/06/17 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/11 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/02/10 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2006/12/22 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/12/22 |
SUPPL-2(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2006/11/01 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/10/12 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/04/28 |
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)