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 |
2018/10/02 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/15 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/10/18 |
SUPPL-18(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/04/28 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/05/10 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2006/02/27 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/08/05 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/05/02 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/12/29 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/12/29 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/09/13 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/12/18 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/12 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/11/15 |
ORIG-1(原始申请) |
Approval |
Type 8 - Partial Rx to OTC Switch |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)