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 |
2024/02/15 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/01/25 |
SUPPL-15(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2018/10/26 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/03/17 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2016/11/03 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/08/24 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/08/24 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/08/24 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/23 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/20 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/02/25 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/05/02 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/01/08 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/27 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/08/13 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/26 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
与本品治疗等效的药品
活性成分:OSPEMIFENE 剂型/给药途径:TABLET;ORAL 规格:60MG 治疗等效代码:AB
申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
203505 |
001 |
NDA |
OSPHENA |
OSPEMIFENE |
TABLET;ORAL |
60MG |
Prescription |
Yes |
Yes |
AB |
2013/02/26
|
DUCHESNAY |
215574 |
001 |
ANDA |
OSPEMIFENE |
OSPEMIFENE |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2024/02/13
|
HETERO LABS LTD V |