ANDA 086032

ANI PHARMS INC

FDA Drug Application

Application #086032

Application Sponsors

ANDA 086032

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1988-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1982-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1985-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-03-29
LABELING; Labeling	SUPPL	26	AP	1988-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1991-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-11-19
LABELING; Labeling	SUPPL	30	AP	1991-09-12
LABELING; Labeling	SUPPL	31	AP	1991-12-19
LABELING; Labeling	SUPPL	32	AP	1992-04-02
LABELING; Labeling	SUPPL	33	AP	1992-11-16
LABELING; Labeling	SUPPL	34	AP	1996-12-10

Submissions Property Types

SUPPL	13	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86032
            [companyName] => ANI PHARMS INC
            [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
        )

)