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 |
2021/09/09 |
SUPPL-16(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/08/21 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/10/03 |
SUPPL-14(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2019/08/22 |
SUPPL-13(补充) |
Approval |
Efficacy |
PRIORITY
;Orphan
|
|
|
2018/10/30 |
SUPPL-12(补充) |
Approval |
Efficacy |
PRIORITY
|
|
|
2018/07/27 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/08/28 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/04 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/06/17 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/15 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/11/25 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2015/04/17 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/04/15 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/09/24 |
ORIG-2(原始申请) |
Approval |
Efficacy |
STANDARD
|
|
|
2014/09/24 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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:COBICISTAT 剂型/给药途径:TABLET;ORAL 规格:150MG 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 |
203094 |
001 |
NDA |
TYBOST |
COBICISTAT |
TABLET;ORAL |
150MG |
Prescription |
Yes |
Yes |
AB |
2014/09/24
|
GILEAD SCIENCES INC |
209986 |
001 |
ANDA |
COBICISTAT |
COBICISTAT |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/02/07
|
MYLAN LABS LTD |
活性成分:COBICISTAT 剂型/给药途径:TABLET;ORAL 规格:150MG 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 |
203094 |
001 |
NDA |
TYBOST |
COBICISTAT |
TABLET;ORAL |
150MG |
Prescription |
Yes |
Yes |
AB |
2014/09/24
|
GILEAD SCIENCES INC |
209986 |
001 |
ANDA |
COBICISTAT |
COBICISTAT |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/02/07
|
MYLAN LABS LTD |