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 |
2023/11/09 |
SUPPL-52(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/07/31 |
SUPPL-47(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/11/25 |
SUPPL-44(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/01/03 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/04/26 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/13 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/01/25 |
SUPPL-34(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2004/07/30 |
SUPPL-22(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2004/07/15 |
SUPPL-23(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/06/25 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/12/09 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/11/27 |
SUPPL-16(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2002/01/30 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/13 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/13 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/02/14 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/10/01 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/12/04 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/29 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/05/04 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/01/23 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/10/06 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1997/03/26 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/08/23 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|