Application Sponsors
| ANDA 209950 | AMNEAL PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 54MG | 0 | FENOFIBRATE | FENOFIBRATE |
| 002 | TABLET;ORAL | 160MG | 0 | FENOFIBRATE | FENOFIBRATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-06-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 209950
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"54MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE","activeIngredients":"FENOFIBRATE","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/25\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/25\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/25\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-25
)
)