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 |
2019/02/22 |
SUPPL-48(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/06/01 |
SUPPL-46(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2018/06/01 |
SUPPL-45(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2017/10/16 |
SUPPL-42(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-40(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2016/08/12 |
SUPPL-41(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/12 |
SUPPL-39(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/10/15 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/10/15 |
SUPPL-34(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/10/15 |
SUPPL-33(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/09/19 |
SUPPL-38(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2014/09/19 |
SUPPL-36(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/09/19 |
SUPPL-32(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/07/28 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2013/02/19 |
SUPPL-30(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2012/12/11 |
SUPPL-31(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2012/01/20 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/11/09 |
SUPPL-25(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/07/22 |
SUPPL-21(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/07/22 |
SUPPL-20(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/07/22 |
SUPPL-19(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2011/06/29 |
SUPPL-24(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2011/02/17 |
SUPPL-18(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/12/17 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/04/22 |
SUPPL-17(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/22 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/02/04 |
SUPPL-15(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/10/19 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/01 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/07/01 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/05/16 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/01/31 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/11/20 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/05/10 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
PRIORITY
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)