ANDA 203519

TRIS PHARMA INC

FDA Drug Application

Application #203519

Application Sponsors

ANDA 203519

TRIS PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

20MG/5ML

0

MORPHINE SULFATE

MORPHINE SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-18
REMS; REMS	SUPPL	2	AP	2018-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203519
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-2","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)