ANDA 089984

AUROLIFE PHARMA LLC

FDA Drug Application

Application #089984

Application Sponsors

ANDA 089984

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

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
LABELING; Labeling	SUPPL	5	AP	1994-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-05-09

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89984
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)