TRIS PHARMA INC FDA Approval NDA 210526

NDA 210526

TRIS PHARMA INC

FDA Drug Application

Application #210526

Documents

Label2021-11-08
Letter2021-11-08
Medication Guide2021-11-08

Application Sponsors

NDA 210526TRIS PHARMA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, EXTENDED RELEASE;ORAL5MG0DYANAVEL XRAMPHETAMINE
002TABLET, EXTENDED RELEASE; ORAL10MG0DYANAVEL XRAMPHETAMINE
003TABLET, EXTENDED RELEASE;ORAL15MG0DYANAVEL XRAMPHETAMINE
004TABLET, EXTENDED RELEASE; ORAL20MG0DYANAVEL XRAMPHETAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2021-11-04STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

TRIS PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210526
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/210526s000lbl.pdf#page=20"]
            [products] => [{"drugName":"DYANAVEL XR","activeIngredients":"AMPHETAMINE","strength":"5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DYANAVEL XR","activeIngredients":"AMPHETAMINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DYANAVEL XR","activeIngredients":"AMPHETAMINE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DYANAVEL XR","activeIngredients":"AMPHETAMINE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/04\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210526s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210526s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210526Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-04
        )

)

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