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 |
|---|
| 2023/07/19 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/06/16 |
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
|
ANCHEN PHARMS |
| 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
|
ANCHEN PHARMS |
| 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 |