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 |
2016/01/06 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2014/04/18 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/10/03 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/04/11 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2012/07/03 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/05/20 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/31 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/10/31 |
SUPPL-5(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2002/10/31 |
SUPPL-4(补充) |
Approval |
Labeling |
PRIORITY
|
|
|
2001/05/08 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1995/05/26 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
;Orphan
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)