AUROLIFE PHARMA LLC FDA Approval ANDA 072396

ANDA 072396

AUROLIFE PHARMA LLC

FDA Drug Application

Application #072396

Application Sponsors

ANDA 072396AUROLIFE PHARMA LLC

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 600MG BASE0FENOPROFEN CALCIUMFENOPROFEN CALCIUM

FDA Submissions

ORIG1AP1988-10-17
LABELING; LabelingSUPPL2AP1989-03-31
BIOEQUIV; BioequivalenceSUPPL3AP1989-02-27
BIOEQUIV; BioequivalenceSUPPL5AP1989-02-27
LABELING; LabelingSUPPL6AP1991-07-30
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1995-04-18
LABELING; LabelingSUPPL8AP2016-05-09STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null15

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
        )

)

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