ANDA 084764

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084764

Application Sponsors

ANDA 084764

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.25MG

0

DEXAMETHASONE

DEXAMETHASONE

FDA Submissions

	ORIG	1	AP	1978-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1983-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1987-08-13
LABELING; Labeling	SUPPL	25	AP	1990-04-02
LABELING; Labeling	SUPPL	26	AP	1991-01-23
LABELING; Labeling	SUPPL	27	AP	1991-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-12-01

Submissions Property Types

SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84764
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)