ANDA 086167

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086167

Application Sponsors

ANDA 086167

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

20MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1983-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1983-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1987-04-01
LABELING; Labeling	SUPPL	32	AP	1990-03-07
LABELING; Labeling	SUPPL	33	AP	1990-07-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1991-09-10
LABELING; Labeling	SUPPL	36	AP	1991-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1992-04-03
LABELING; Labeling	SUPPL	38	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1995-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1998-12-01

Submissions Property Types

SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	40	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86167
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)