Application Sponsors
| ANDA 209951 | AMNEAL PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 48MG | 0 | FENOFIBRATE | FENOFIBRATE |
| 002 | TABLET;ORAL | 145MG | 0 | FENOFIBRATE | FENOFIBRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-09-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-04-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 209951
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"48MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"145MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-23
)
)