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
>>>原始批准或临时批准<<<
审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
2005/08/12 |
ORIG-1(原始申请) |
Approval |
Type 4 - New Combination |
STANDARD
|
|
|
>>>补充申请<<<
审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
2015/04/08 |
SUPPL-11(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2015/03/26 |
SUPPL-10(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2013/04/19 |
SUPPL-9(补充) |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
2011/08/22 |
SUPPL-8(补充) |
Approval |
REMS-Assessment |
N/A
|
|
|
2011/01/25 |
SUPPL-7(补充) |
Approval |
Labeling-Container/Carton Labels |
UNKNOWN
|
|
|
2011/01/25 |
SUPPL-6(补充) |
Approval |
REMS-Proposal |
N/A
|
|
|
2006/08/22 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/06/19 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/01/24 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)