ANDA 089698

MIKART

FDA Drug Application

Application #089698

Application Sponsors

ANDA 089698

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG;2.5MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1989-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-06-30
LABELING; Labeling	SUPPL	11	AP	1997-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-07-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-06-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	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	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89698
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)