ANDA 086169

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086169

Application Sponsors

ANDA 086169

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1983-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1991-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1987-03-31
LABELING; Labeling	SUPPL	36	AP	1990-03-07
LABELING; Labeling	SUPPL	37	AP	1990-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1991-09-10
LABELING; Labeling	SUPPL	40	AP	1991-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-04-03
LABELING; Labeling	SUPPL	42	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1998-12-01

Submissions Property Types

SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86169
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)