AUROLIFE PHARMA LLC FDA Approval ANDA 211639

ANDA 211639

AUROLIFE PHARMA LLC

FDA Drug Application

Application #211639

Application Sponsors

ANDA 211639AUROLIFE PHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE
002TABLET;ORAL10MG0AMPHETAMINE SULFATEAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2019-04-17STANDARD
LABELING; LabelingSUPPL2AP2022-02-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

AUROLIFE PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211639
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-17
        )

)

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