NDA 210526

TRIS PHARMA INC

FDA Drug Application

Application #210526

Documents

• Label: 2021-11-08
• Letter: 2021-11-08
• Medication Guide: 2021-11-08
• Letter: 2022-02-28
• Label: 2022-03-02
• Medication Guide: 2022-03-02
• Review: 2022-03-21
• Letter: 2022-06-02
• Label: 2022-06-06
• Letter: 2022-10-17

Application Sponsors

NDA 210526

TRIS PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	5MG	0	DYANAVEL XR	AMPHETAMINE
002	TABLET, EXTENDED RELEASE; ORAL	10MG	0	DYANAVEL XR	AMPHETAMINE
003	TABLET, EXTENDED RELEASE;ORAL	15MG	0	DYANAVEL XR	AMPHETAMINE
004	TABLET, EXTENDED RELEASE; ORAL	20MG	0	DYANAVEL XR	AMPHETAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2021-11-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-10-14	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-02-25	901 REQUIRED

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	3	Null	7

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
        )

)