TRIS PHARMA INC FDA Approval ANDA 206095

ANDA 206095

TRIS PHARMA INC

FDA Drug Application

Application #206095

Application Sponsors

ANDA 206095TRIS PHARMA INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE
002TABLET;ORAL10MG0DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA

CDER Filings

TRIS PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206095
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"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":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-18
        )

)

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