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 |
2024/04/04 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2024/02/20 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2023/10/06 |
SUPPL-50(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/03/06 |
SUPPL-43(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/10/09 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2009/06/02 |
SUPPL-33(补充) |
Approval |
Labeling |
|
|
|
2008/07/14 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
2002/09/10 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
2001/10/04 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/10/04 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/01/21 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/10 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/10 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/09/18 |
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 |