ANDA 089008

MIKART

FDA Drug Application

Application #089008

Application Sponsors

ANDA 089008

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

500MG;5MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1986-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-03-31
LABELING; Labeling	SUPPL	10	AP	1992-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1990-06-04
LABELING; Labeling	SUPPL	20	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1991-02-13
LABELING; Labeling	SUPPL	22	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1989-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1991-02-13
LABELING; Labeling	SUPPL	27	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1991-02-13
LABELING; Labeling	SUPPL	30	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1991-02-13
BIOEQUIV; Bioequivalence	SUPPL	36	AP	1989-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1991-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1990-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1992-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1995-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1995-08-11
LABELING; Labeling	SUPPL	45	AP	1996-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	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	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89008
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)