ANDA 203644

TRIS PHARMA INC

FDA Drug Application

Application #203644

Application Sponsors

ANDA 203644

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

DEXTROAMPHETAMINE SULFATE

DEXTROAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-05-29
LABELING; Labeling	SUPPL	3	AP	2016-12-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203644
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/27\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-04
        )

)