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 |
2021/04/28 |
SUPPL-39(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/02 |
SUPPL-38(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/02 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/05/09 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/04/28 |
SUPPL-29(补充) |
Approval |
Labeling |
|
|
|
2006/06/27 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
2002/09/26 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/08/22 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1998/02/25 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/02/05 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/04/16 |
SUPPL-16(补充) |
Approval |
Labeling |
|
|
|
1994/05/02 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1993/10/05 |
SUPPL-15(补充) |
Approval |
Labeling |
|
|
|
1993/04/20 |
SUPPL-12(补充) |
Approval |
Labeling |
|
|
|
1992/12/10 |
SUPPL-11(补充) |
Approval |
Labeling |
|
|
|
1990/01/31 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/11/20 |
SUPPL-9(补充) |
Approval |
Labeling |
|
|
|
1989/06/30 |
SUPPL-8(补充) |
Approval |
Labeling |
|
|
|
1989/02/16 |
SUPPL-7(补充) |
Approval |
Labeling |
|
|
|
1988/04/14 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1987/09/24 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/08/14 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/06/20 |
SUPPL-4(补充) |
Approval |
Labeling |
|
|
|
1986/04/08 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1985/09/04 |
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 |