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 |
2017/02/23 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/03 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2002/04/30 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/01/16 |
SUPPL-22(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/10/02 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/12/15 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1999/09/02 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1997/09/25 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/08/13 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1991/10/28 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/09/28 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/11/09 |
SUPPL-13(补充) |
Approval |
Labeling |
|
|
|
1988/07/26 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/14 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/14 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/01/31 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1980/11/07 |
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 |