Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
002 | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | 0 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-07-05 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 210469
[companyName] => TWI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 45MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRIC ACID","activeIngredients":"CHOLINE FENOFIBRATE","strength":"EQ 135MG FENOFIBRIC ACID","dosageForm":"CAPSULE, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-07-05
)
)