ANDA 086067

HIKMA INTL PHARMS

FDA Drug Application

Application #086067

Application Sponsors

ANDA 086067

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1987-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-05-15
LABELING; Labeling	SUPPL	20	AP	1988-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-06-16
LABELING; Labeling	SUPPL	22	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1991-02-13
LABELING; Labeling	SUPPL	28	AP	1991-05-13
LABELING; Labeling	SUPPL	29	AP	1992-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1994-04-12
LABELING; Labeling	SUPPL	31	AP	1994-04-12
LABELING; Labeling	SUPPL	32	AP	1997-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2001-03-07
LABELING; Labeling	SUPPL	36	AP	2000-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2001-04-11
LABELING; Labeling	SUPPL	38	AP	2002-07-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2016-09-26
LABELING; Labeling	SUPPL	45	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	46	AP	2016-01-04	STANDARD

Submissions Property Types

SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	40	Null	7
SUPPL	45	Null	7
SUPPL	46	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86067
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)