WINDER LABS LLC FDA Approval ANDA 212160

ANDA 212160

WINDER LABS LLC

FDA Drug Application

Application #212160

Application Sponsors

ANDA 212160WINDER LABS LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001TABLET;ORAL2.5MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
002TABLET;ORAL5MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
003TABLET;ORAL7.5MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
004TABLET;ORAL10MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
005TABLET;ORAL15MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
006TABLET;ORAL20MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
007TABLET;ORAL30MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA
004PrescriptionAA
005PrescriptionAA
006PrescriptionAA
007PrescriptionAA

CDER Filings

WINDER LABS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212160
            [companyName] => WINDER LABS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-07
        )

)

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