TWI PHARMS FDA Approval ANDA 210469

ANDA 210469

TWI PHARMS

FDA Drug Application

Application #210469

Application Sponsors

ANDA 210469TWI PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE, DELAYED RELEASE;ORALEQ 45MG FENOFIBRIC ACID0FENOFIBRIC ACIDCHOLINE FENOFIBRATE
002CAPSULE, DELAYED RELEASE;ORALEQ 135MG FENOFIBRIC ACID0FENOFIBRIC ACIDCHOLINE FENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2019-07-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

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
        )

)

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