ANDA 079058

TRIS PHARMA INC

FDA Drug Application

Application #079058

Application Sponsors

ANDA 079058

TRIS PHARMA INC

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION/DROPS;ORAL

40MG/ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2009-08-31
LABELING; Labeling	SUPPL	2	AP	2017-05-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-05-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-05-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15

CDER Filings

TRIS PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79058
            [companyName] => TRIS PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"40MG\/ML","dosageForm":"SUSPENSION\/DROPS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"40MG\/ML","submissionClassification":"SUSPENSION\/DROPS;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)