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 |
2023/10/24 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/07/05 |
ORIG-1(原始申请) |
Approval |
|
STANDARD
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
无 |
与本品治疗等效的药品
活性成分:CHOLINE FENOFIBRATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:EQ 45MG FENOFIBRIC ACID 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 |
022224 |
001 |
NDA |
TRILIPIX |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
Yes |
No |
AB |
2008/12/15
|
ABBVIE |
201573 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Discontinued |
No |
No |
AB |
2013/07/18
|
ENDO OPERATIONS |
200750 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2013/12/04
|
CHARTWELL RX |
200920 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2015/10/07
|
ACTAVIS ELIZABETH |
200264 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2016/09/07
|
IMPAX LABS INC |
208705 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2017/05/12
|
ALEMBIC |
210469 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/05
|
TWI PHARMS |
211626 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/18
|
GRAVITI PHARMS |
212598 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/25
|
AUROBINDO PHARMA LTD |
213450 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2020/06/16
|
MICRO LABS |
212562 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2020/12/23
|
YICHANG HUMANWELL |
207796 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 45MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2024/02/08
|
MACLEODS PHARMS LTD |
活性成分:CHOLINE FENOFIBRATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:EQ 135MG FENOFIBRIC ACID 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 |
022224 |
002 |
NDA |
TRILIPIX |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
Yes |
Yes |
AB |
2008/12/15
|
ABBVIE |
201573 |
001 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Discontinued |
No |
No |
AB |
2013/07/18
|
ENDO OPERATIONS |
200750 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2013/12/04
|
CHARTWELL RX |
200920 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2015/10/07
|
ACTAVIS ELIZABETH |
200264 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2016/09/07
|
IMPAX LABS INC |
208705 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2017/05/12
|
ALEMBIC |
210469 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/05
|
TWI PHARMS |
211626 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/18
|
GRAVITI PHARMS |
212598 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2019/07/25
|
AUROBINDO PHARMA LTD |
213450 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2020/06/16
|
MICRO LABS |
212562 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2020/12/23
|
YICHANG HUMANWELL |
207796 |
002 |
ANDA |
FENOFIBRIC ACID |
CHOLINE FENOFIBRATE |
CAPSULE, DELAYED RELEASE;ORAL |
EQ 135MG FENOFIBRIC ACID |
Prescription |
No |
No |
AB |
2024/02/08
|
MACLEODS PHARMS LTD |