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 |
2019/10/03 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/18 |
SUPPL-32(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/10/14 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/11/14 |
SUPPL-28(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/01 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2010/04/01 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2009/12/16 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/05/01 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/05/05 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/12/26 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/11/29 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/07/27 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/12/13 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/07/02 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/06/04 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/11/25 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|