ALEMBIC PHARMS LTD FDA Approval ANDA 213842

ANDA 213842

ALEMBIC PHARMS LTD

FDA Drug Application

Application #213842

Application Sponsors

ANDA 213842ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL67MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE
002CAPSULE;ORAL134MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE
003CAPSULE;ORAL200MG0FENOFIBRATE (MICRONIZED)FENOFIBRATE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213842
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"67MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"134MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FENOFIBRATE (MICRONIZED)","activeIngredients":"FENOFIBRATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-19
        )

)

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