APOTEX FDA Approval ANDA 209437

ANDA 209437

APOTEX

FDA Drug Application

Application #209437

Application Sponsors

ANDA 209437APOTEX

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL1GM0ICOSAPENT ETHYLICOSAPENT ETHYL

FDA Submissions

UNKNOWN; ORIG1AP2021-06-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209437
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICOSAPENT ETHYL","activeIngredients":"ICOSAPENT ETHYL","strength":"1GM","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-30
        )

)

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