ANDA 087545

SUN PHARM INDUSTRIES

FDA Drug Application

Application #087545

Application Sponsors

ANDA 087545

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

10MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	1	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-04-02
LABELING; Labeling	SUPPL	8	AP	1990-03-07
LABELING; Labeling	SUPPL	9	AP	1990-07-25
LABELING; Labeling	SUPPL	10	AP	1991-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-04-03
LABELING; Labeling	SUPPL	12	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-12-01

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87545
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"10MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)