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 |
2023/06/15 |
SUPPL-55(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/25 |
SUPPL-54(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2023/04/25 |
SUPPL-56(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/02/18 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/08/01 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/04/24 |
SUPPL-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/04/02 |
SUPPL-45(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/07/27 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/04/05 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/07/06 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/07/29 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/05/02 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/12/30 |
SUPPL-33(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2009/11/13 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2007/08/31 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/08/12 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/03/12 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2003/04/25 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/30 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/11 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/11/05 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/01/04 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/10/24 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/27 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/12/27 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/25 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/11/03 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/07/23 |
SUPPL-2(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
1997/06/05 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/05/30 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/05/10 |
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)
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 |
无 |