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 |
2017/02/08 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/07/26 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/23 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/08/14 |
SUPPL-32(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2012/04/27 |
SUPPL-28(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2011/10/11 |
SUPPL-31(补充) |
Approval |
REMS |
N/A
|
|
|
2011/10/11 |
SUPPL-29(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/06/09 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/02/25 |
SUPPL-25(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2009/04/27 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/03/12 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/10/03 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/05 |
SUPPL-15(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2008/04/16 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/12/13 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/11/16 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/11/15 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/09/14 |
SUPPL-9(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2007/09/11 |
SUPPL-11(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2007/06/19 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/31 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/10 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/06/23 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/01/20 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/08/04 |
SUPPL-2(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2004/11/24 |
SUPPL-3(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2004/10/21 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)