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 |
|---|
| 2021/06/03 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/09/23 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/02/14 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 2010/11/22 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2010/09/02 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2010/05/03 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/10/25 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2007/10/25 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2005/12/29 |
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:54MG 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 |
|---|
| 076433 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2005/05/13
|
RHODES PHARMS |
| 076635 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Discontinued |
No |
No |
AB |
2005/10/31
|
SUN PHARM INDS LTD |
| 076520 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2007/10/25
|
MYLAN |
| 076509 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2008/03/26
|
IMPAX LABS |
| 204019 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2015/08/17
|
LUPIN LTD |
| 207803 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2017/12/19
|
AUSTARPHARMA |
| 209950 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2018/03/19
|
AMNEAL |
| 210138 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2018/07/23
|
AJANTA PHARMA LTD |
| 210606 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2018/08/17
|
RISING |
| 209660 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2019/02/11
|
CHARTWELL RX |
| 210670 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2019/09/06
|
DR REDDYS |
| 213864 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2020/06/12
|
MANKIND PHARMA |
| 216798 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2022/09/27
|
AUROBINDO PHARMA |
| 218548 |
001 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
54MG |
Prescription |
No |
No |
AB |
2024/04/24
|
YICHANG HUMANWELL |
活性成分:FENOFIBRATE 剂型/给药途径:TABLET;ORAL 规格:160MG 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 |
|---|
| 076433 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2005/05/13
|
RHODES PHARMS |
| 076635 |
003 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Discontinued |
No |
No |
AB |
2005/10/31
|
SUN PHARM INDS LTD |
| 076520 |
003 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2007/10/25
|
MYLAN |
| 076509 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
Yes |
AB |
2008/03/26
|
IMPAX LABS |
| 204019 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2015/08/17
|
LUPIN LTD |
| 207803 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2017/12/19
|
AUSTARPHARMA |
| 209950 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2018/03/19
|
AMNEAL |
| 210138 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2018/07/23
|
AJANTA PHARMA LTD |
| 210606 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2018/08/17
|
RISING |
| 209660 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2019/02/11
|
CHARTWELL RX |
| 210670 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2019/09/06
|
DR REDDYS |
| 213864 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2020/06/12
|
MANKIND PHARMA |
| 216798 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2022/09/27
|
AUROBINDO PHARMA |
| 218548 |
002 |
ANDA |
FENOFIBRATE |
FENOFIBRATE |
TABLET;ORAL |
160MG |
Prescription |
No |
No |
AB |
2024/04/24
|
YICHANG HUMANWELL |