ANDA 086054

HIKMA INTL PHARMS

FDA Drug Application

Application #086054

Application Sponsors

ANDA 086054

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

2.5MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1987-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1982-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1982-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1984-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-08-25
LABELING; Labeling	SUPPL	26	AP	1988-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1988-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1991-07-18
LABELING; Labeling	SUPPL	30	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1991-02-13
LABELING; Labeling	SUPPL	34	AP	1991-03-27
LABELING; Labeling	SUPPL	35	AP	1992-12-04
LABELING; Labeling	SUPPL	36	AP	1994-07-06
LABELING; Labeling	SUPPL	37	AP	1997-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-10-01
LABELING; Labeling	SUPPL	39	AP	2000-10-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2001-04-03
LABELING; Labeling	SUPPL	41	AP	2002-07-01

Submissions Property Types

SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86054
            [companyName] => HIKMA INTL PHARMS
            [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
        )

)