ANDA 087425

HIKMA INTL PHARMS

FDA Drug Application

Application #087425

Application Sponsors

ANDA 087425

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

300MG

0

ISONIAZID

ISONIAZID

FDA Submissions

	ORIG	1	AP	1981-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-10-23
LABELING; Labeling	SUPPL	15	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-08-12
LABELING; Labeling	SUPPL	20	AP	1997-08-12
LABELING; Labeling	SUPPL	21	AP	1997-02-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-10-01
LABELING; Labeling	SUPPL	31	AP	2008-10-21

Submissions Property Types

SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87425
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)