ANDA 086596

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086596

Application Sponsors

ANDA 086596

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

PREDNISONE

PREDNISONE

FDA Submissions

	ORIG	1	AP	1979-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-04-01
LABELING; Labeling	SUPPL	15	AP	1991-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-04-03
LABELING; Labeling	SUPPL	19	AP	1994-04-04
LABELING; Labeling	SUPPL	20	AP	1995-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-12-01

Submissions Property Types

SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86596
            [companyName] => SUN PHARM INDUSTRIES
            [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
        )

)