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 |
2023/10/17 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/12/18 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/21 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/02/09 |
SUPPL-31(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/02/17 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/08/18 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/05/29 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2015/01/22 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/07/18 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2005/04/26 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/11/27 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/11/27 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/11/27 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/11/27 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2002/10/29 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1992/12/22 |
SUPPL-10(补充) |
Approval |
Labeling |
|
|
|
1988/05/25 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1986/08/25 |
SUPPL-5(补充) |
Approval |
Efficacy |
|
|
|
1985/07/15 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1979/10/18 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1977/09/14 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1976/07/21 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
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 |
001 |
6803046 |
2022/08/16 |
|
Y |
|
|
|
PDF格式 | **本条是由Drugfuture回溯的历史信息** |