ANDA 088863

SUN PHARM INDUSTRIES

FDA Drug Application

Application #088863

Application Sponsors

ANDA 088863

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

PHENYLBUTAZONE

PHENYLBUTAZONE

FDA Submissions

	ORIG	1	AP	1985-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-03-03
LABELING; Labeling	SUPPL	9	AP	1989-06-28
LABELING; Labeling	SUPPL	10	AP	1989-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-12-01

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88863
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLBUTAZONE","activeIngredients":"PHENYLBUTAZONE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYLBUTAZONE","submission":"PHENYLBUTAZONE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)