ANDA 072396

AUROLIFE PHARMA LLC

FDA Drug Application

Application #072396

Application Sponsors

ANDA 072396

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

FENOPROFEN CALCIUM

FENOPROFEN CALCIUM

FDA Submissions

	ORIG	1	AP	1988-10-17
LABELING; Labeling	SUPPL	2	AP	1989-03-31
BIOEQUIV; Bioequivalence	SUPPL	3	AP	1989-02-27
BIOEQUIV; Bioequivalence	SUPPL	5	AP	1989-02-27
LABELING; Labeling	SUPPL	6	AP	1991-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-04-18
LABELING; Labeling	SUPPL	8	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72396
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FENOPROFEN CALCIUM","activeIngredients":"FENOPROFEN CALCIUM","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FENOPROFEN CALCIUM","submission":"FENOPROFEN CALCIUM","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)