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 |
2024/04/19 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/08/18 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/03/24 |
SUPPL-10(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2021/09/20 |
SUPPL-7(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2019/10/07 |
SUPPL-6(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2017/12/19 |
SUPPL-5(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2017/01/04 |
SUPPL-4(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2015/06/05 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/07/18 |
SUPPL-2(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2014/05/23 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/07/25 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
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:LEVOMILNACIPRAN HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 20MG BASE 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 |
204168 |
001 |
NDA |
FETZIMA |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 20MG BASE |
Prescription |
Yes |
No |
AB |
2013/07/25
|
ABBVIE |
210826 |
001 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2023/01/06
|
AUROBINDO PHARMA LTD |
210771 |
001 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2023/03/20
|
PRINSTON INC |
活性成分:LEVOMILNACIPRAN HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 40MG BASE 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 |
204168 |
002 |
NDA |
FETZIMA |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
Yes |
No |
AB |
2013/07/25
|
ABBVIE |
210826 |
002 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 40MG BASE |
Discontinued |
No |
No |
AB |
2023/01/06
|
AUROBINDO PHARMA LTD |
210771 |
002 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 40MG BASE |
Prescription |
No |
No |
AB |
2023/03/20
|
PRINSTON INC |
活性成分:LEVOMILNACIPRAN HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 80MG BASE 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 |
204168 |
003 |
NDA |
FETZIMA |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 80MG BASE |
Prescription |
Yes |
No |
AB |
2013/07/25
|
ABBVIE |
210826 |
003 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 80MG BASE |
Discontinued |
No |
No |
AB |
2023/01/06
|
AUROBINDO PHARMA LTD |
210771 |
003 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 80MG BASE |
Prescription |
No |
No |
AB |
2023/03/20
|
PRINSTON INC |
活性成分:LEVOMILNACIPRAN HYDROCHLORIDE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:EQ 120MG BASE 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 |
204168 |
004 |
NDA |
FETZIMA |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 120MG BASE |
Prescription |
Yes |
Yes |
AB |
2013/07/25
|
ABBVIE |
210826 |
004 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 120MG BASE |
Discontinued |
No |
No |
AB |
2023/01/06
|
AUROBINDO PHARMA LTD |
210771 |
004 |
ANDA |
LEVOMILNACIPRAN HYDROCHLORIDE |
LEVOMILNACIPRAN HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
EQ 120MG BASE |
Prescription |
No |
No |
AB |
2023/03/20
|
PRINSTON INC |