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 |
2024/11/21 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/30 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/07/22 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/05/09 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/12/01 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/12/23 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/10/11 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/04/03 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/08/12 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1989/09/20 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1989/07/12 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1988/12/16 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/11 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/05/11 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/25 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/02/18 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |