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-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/05/15 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/05/18 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/05/18 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/02/07 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2003/07/31 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2003/07/31 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2002/09/03 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/04/09 |
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:CAPSULE;ORAL 规格:67MG 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 |
|---|
| 075753 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2002/09/03
|
RHODES PHARMS |
| 075868 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Discontinued |
No |
No |
AB |
2003/10/27
|
IMPAX LABS |
| 207378 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Discontinued |
No |
No |
AB |
2017/03/28
|
INVAGEN PHARMS |
| 205566 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2017/04/07
|
GLENMARK PHARMS LTD |
| 207805 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2017/11/16
|
REYOUNG |
| 209504 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2018/04/30
|
ANI PHARMS |
| 210782 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2018/06/26
|
TORRENT |
| 210705 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AJANTA PHARMA LTD |
| 213842 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2020/10/19
|
ALEMBIC |
| 212232 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2021/09/20
|
AUROBINDO PHARMA LTD |
| 211407 |
001 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
67MG |
Prescription |
No |
No |
AB |
2024/01/31
|
CHARTWELL |
活性成分:FENOFIBRATE 剂型/给药途径:CAPSULE;ORAL 规格:134MG 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 |
|---|
| 075753 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2002/04/09
|
RHODES PHARMS |
| 075868 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Discontinued |
No |
No |
AB |
2003/10/27
|
IMPAX LABS |
| 207378 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Discontinued |
No |
No |
AB |
2017/03/28
|
INVAGEN PHARMS |
| 205566 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2017/04/07
|
GLENMARK PHARMS LTD |
| 207805 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2017/11/16
|
REYOUNG |
| 209504 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2018/04/30
|
ANI PHARMS |
| 210782 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2018/06/26
|
TORRENT |
| 210705 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AJANTA PHARMA LTD |
| 213842 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2020/10/19
|
ALEMBIC |
| 212232 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2021/09/20
|
AUROBINDO PHARMA LTD |
| 211407 |
002 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
134MG |
Prescription |
No |
No |
AB |
2024/01/31
|
CHARTWELL |
活性成分:FENOFIBRATE 剂型/给药途径:CAPSULE;ORAL 规格:200MG 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 |
|---|
| 075753 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2002/04/09
|
RHODES PHARMS |
| 075868 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2003/10/27
|
IMPAX LABS |
| 207378 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2017/03/28
|
INVAGEN PHARMS |
| 205566 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2017/04/07
|
GLENMARK PHARMS LTD |
| 207805 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2017/11/16
|
REYOUNG |
| 209504 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2018/04/30
|
ANI PHARMS |
| 210782 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2018/06/26
|
TORRENT |
| 210705 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
Yes |
AB |
2018/09/10
|
AJANTA PHARMA LTD |
| 213842 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/10/19
|
ALEMBIC |
| 212232 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/09/20
|
AUROBINDO PHARMA LTD |
| 211407 |
003 |
ANDA |
FENOFIBRATE (MICRONIZED) |
FENOFIBRATE |
CAPSULE;ORAL |
200MG |
Prescription |
No |
No |
AB |
2024/01/31
|
CHARTWELL |
