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 |
2015/09/30 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/12/11 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/12/19 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/12/11 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/07/09 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/04/11 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/04/05 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/08 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/31 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/31 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/15 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/15 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/12/13 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2012/12/10 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/06/02 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/07/30 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/07/14 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/05/15 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/20 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|