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 |
|---|
| 2019/09/23 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/10/15 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2014/11/03 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/12/23 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:FENOFIBRATE 剂型/给药途径:TABLET;ORAL 规格:48MG 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 |
|---|
| 021656 |
001 |
NDA |
TRICOR |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Discontinued |
Yes |
No |
AB |
2004/11/05
|
ABBVIE |
| 090856 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2011/12/23
|
LUPIN LTD |
| 090715 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2012/04/05
|
VALEANT PHARMS NORTH |
| 202856 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2012/12/07
|
MYLAN PHARMS INC |
| 205118 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2016/05/05
|
AUROBINDO PHARMA |
| 204598 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2016/07/12
|
HETERO LABS LTD III |
| 208709 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2016/12/15
|
CIPLA |
| 200884 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2017/09/07
|
SUN PHARM |
| 209951 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2018/02/09
|
AMNEAL |
| 211080 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2018/08/28
|
PRINSTON INC |
| 210476 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2019/08/09
|
ALEMBIC |
| 211122 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2020/03/18
|
RISING |
| 208476 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2021/02/10
|
AUSTARPHARMA |
| 210248 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
48MG |
Prescription |
No |
No |
AB |
2024/11/13
|
MACLEODS PHARMS LTD |
活性成分:FENOFIBRATE 剂型/给药途径:TABLET;ORAL 规格:145MG 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 |
|---|
| 021656 |
002 |
NDA |
TRICOR |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Discontinued |
Yes |
No |
AB |
2004/11/05
|
ABBVIE |
| 090856 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2011/12/23
|
LUPIN LTD |
| 090715 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2012/04/05
|
VALEANT PHARMS NORTH |
| 202856 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2012/12/07
|
MYLAN PHARMS INC |
| 205118 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
Yes |
AB |
2016/05/05
|
AUROBINDO PHARMA |
| 204598 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2016/07/12
|
HETERO LABS LTD III |
| 208709 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2016/12/15
|
CIPLA |
| 200884 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2017/09/07
|
SUN PHARM |
| 209951 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2018/02/09
|
AMNEAL |
| 211080 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2018/08/28
|
PRINSTON INC |
| 210476 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2019/08/09
|
ALEMBIC |
| 211122 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2020/03/18
|
RISING |
| 208476 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2021/02/10
|
AUSTARPHARMA |
| 210248 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
145MG |
Prescription |
No |
No |
AB |
2024/11/13
|
MACLEODS PHARMS LTD |
