ANDA 088088

HIKMA INTL PHARMS

FDA Drug Application

Application #088088

Application Sponsors

ANDA 088088

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1987-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-05-11
LABELING; Labeling	SUPPL	8	AP	1988-10-14
LABELING; Labeling	SUPPL	9	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-02-09
LABELING; Labeling	SUPPL	16	AP	1991-05-13
LABELING; Labeling	SUPPL	17	AP	1992-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-04-12
LABELING; Labeling	SUPPL	19	AP	1994-04-12
LABELING; Labeling	SUPPL	20	AP	1997-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-03-07
LABELING; Labeling	SUPPL	24	AP	2000-04-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-04-11
LABELING; Labeling	SUPPL	26	AP	2002-07-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2007-03-30
LABELING; Labeling	SUPPL	33	AP	2016-01-04	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2020-05-12	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	15
SUPPL	41	Null	7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88088
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)