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 |
2022/12/29 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/06/23 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/03/01 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/09 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/11/28 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/24 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/06/30 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/06/12 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/09/19 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/23 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/04/05 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/10/31 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/09/27 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/19 |
SUPPL-13(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/01/26 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/12/01 |
SUPPL-8(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/09/15 |
SUPPL-4(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/01 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2009/05/18 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |