ANDA 206095

TRIS PHARMA INC

FDA Drug Application

Application #206095

Application Sponsors

ANDA 206095

TRIS PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
002	TABLET;ORAL	10MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA

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
        )

)