ANDA 084204

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084204

Application Sponsors

ANDA 084204

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

2.5MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1978-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1986-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1986-09-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1987-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1987-03-25
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
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1992-04-03
LABELING; Labeling	SUPPL	35	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-12-01

Submissions Property Types

SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84204
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"2.5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"2.5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)