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 |
2024/08/07 |
SUPPL-157(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2024/07/31 |
SUPPL-158(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2024/06/17 |
SUPPL-155(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2024/06/07 |
SUPPL-154(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2024/03/11 |
SUPPL-160(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2024/01/25 |
SUPPL-124(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2024/01/12 |
SUPPL-147(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2023/12/15 |
SUPPL-152(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2023/12/15 |
SUPPL-151(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2023/11/16 |
SUPPL-143(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/11/07 |
SUPPL-148(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/10/31 |
SUPPL-145(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/10/31 |
SUPPL-144(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/10/23 |
SUPPL-142(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/10/16 |
SUPPL-139(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/10/12 |
SUPPL-138(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/08/14 |
SUPPL-135(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/08/14 |
SUPPL-134(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2023/04/03 |
SUPPL-136(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2023/03/28 |
SUPPL-132(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/01/26 |
SUPPL-128(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/12/16 |
SUPPL-127(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/08/05 |
SUPPL-133(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/06/21 |
SUPPL-131(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/05/20 |
SUPPL-123(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/03/21 |
SUPPL-110(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2022/02/04 |
SUPPL-125(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/02/04 |
SUPPL-95(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/12/17 |
SUPPL-120(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/12/03 |
SUPPL-112(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2021/11/17 |
SUPPL-113(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/10/13 |
SUPPL-122(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/10/13 |
SUPPL-121(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/08/31 |
SUPPL-118(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/08/31 |
SUPPL-117(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/08/10 |
SUPPL-102(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/08/03 |
SUPPL-104(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/07/26 |
SUPPL-114(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/07/26 |
SUPPL-89(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/07/21 |
SUPPL-105(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2021/07/01 |
SUPPL-100(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/06/28 |
SUPPL-108(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/05/05 |
SUPPL-97(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2021/03/30 |
SUPPL-106(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2021/03/22 |
SUPPL-96(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2021/03/16 |
SUPPL-93(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/03/16 |
SUPPL-91(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/02/10 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2020/11/13 |
SUPPL-88(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/11/10 |
SUPPL-48(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/10/14 |
SUPPL-85(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2020/10/02 |
SUPPL-70(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/06/29 |
SUPPL-84(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/06/24 |
SUPPL-92(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/06/24 |
SUPPL-68(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/06/16 |
SUPPL-90(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/06/16 |
SUPPL-71(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-83(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-82(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2020/04/28 |
SUPPL-81(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2020/04/28 |
SUPPL-80(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-79(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-78(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-77(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-76(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2020/04/28 |
SUPPL-69(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2020/04/28 |
SUPPL-64(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/04/28 |
SUPPL-63(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/04/28 |
SUPPL-62(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/04/28 |
SUPPL-61(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/04/28 |
SUPPL-60(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/04/28 |
SUPPL-59(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2020/01/09 |
SUPPL-67(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/01/08 |
SUPPL-66(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/09/17 |
SUPPL-65(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/07/30 |
SUPPL-56(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/07/30 |
SUPPL-55(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/06/17 |
SUPPL-53(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/06/10 |
SUPPL-52(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/04/19 |
SUPPL-54(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/04/11 |
SUPPL-47(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2019/02/15 |
SUPPL-40(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2018/12/28 |
SUPPL-37(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2018/12/19 |
SUPPL-45(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/11/09 |
SUPPL-42(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/10/30 |
SUPPL-41(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/08/20 |
SUPPL-35(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/08/16 |
SUPPL-46(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/06/19 |
SUPPL-43(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/06/13 |
SUPPL-30(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/06/12 |
SUPPL-34(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/11/29 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/09/22 |
SUPPL-24(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2017/07/27 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/07/27 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/23 |
SUPPL-14(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/05/18 |
SUPPL-18(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/05/18 |
SUPPL-17(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/05/17 |
SUPPL-13(补充) |
Approval |
Efficacy |
STANDARD
;Orphan
|
|
|
2017/05/10 |
SUPPL-16(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2017/03/14 |
SUPPL-15(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2016/10/24 |
SUPPL-12(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2016/10/24 |
SUPPL-8(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2016/08/05 |
SUPPL-9(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2015/12/18 |
SUPPL-6(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2015/12/18 |
SUPPL-4(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2015/10/02 |
SUPPL-5(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2015/06/19 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2014/09/04 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
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