ANDA 084765

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084765

Application Sponsors

ANDA 084765

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.75MG

0

DEXAMETHASONE

DEXAMETHASONE

FDA Submissions

	ORIG	1	AP	1978-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1985-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-03-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-10-30
LABELING; Labeling	SUPPL	21	AP	1990-04-02
LABELING; Labeling	SUPPL	22	AP	1991-02-07
LABELING; Labeling	SUPPL	23	AP	1991-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1998-12-01

Submissions Property Types

SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84765
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE","activeIngredients":"DEXAMETHASONE","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE","submission":"DEXAMETHASONE","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)