MICRO LABS FDA Approval ANDA 213450

ANDA 213450

MICRO LABS

FDA Drug Application

Application #213450

Application Sponsors

ANDA 213450MICRO LABS

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; ORIG1AP2020-06-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MICRO LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213450
            [companyName] => MICRO LABS
            [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":"06\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-16
        )

)

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