ANDA 086166

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086166

Application Sponsors

ANDA 086166

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

5MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1987-03-31
LABELING; Labeling	SUPPL	29	AP	1990-03-07
LABELING; Labeling	SUPPL	30	AP	1990-07-25
LABELING; Labeling	SUPPL	31	AP	1991-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1992-04-03
LABELING; Labeling	SUPPL	33	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-12-01

Submissions Property Types

SUPPL	12	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	32	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86166
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)