ANDA 089983

AUROLIFE PHARMA LLC

FDA Drug Application

Application #089983

Application Sponsors

ANDA 089983

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

PREDNISONE

PREDNISONE

FDA Submissions

	ORIG	1	AP	1989-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-05-09

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89983
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)