ANDA 087564

SUN PHARM INDUSTRIES

FDA Drug Application

Application #087564

Application Sponsors

ANDA 087564

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

30MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	1	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-08-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-02-17
LABELING; Labeling	SUPPL	10	AP	1990-03-07
LABELING; Labeling	SUPPL	11	AP	1990-07-25
LABELING; Labeling	SUPPL	12	AP	1991-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-04-03
LABELING; Labeling	SUPPL	14	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-12-01

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87564
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)