ANDA 089689

MIKART

FDA Drug Application

Application #089689

Application Sponsors

ANDA 089689

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG;7.5MG

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1988-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-12-18
LABELING; Labeling	SUPPL	5	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-12-18
LABELING; Labeling	SUPPL	8	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1990-12-18
LABELING; Labeling	SUPPL	11	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1993-02-25
LABELING; Labeling	SUPPL	14	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-10-15
LABELING; Labeling	SUPPL	17	AP	1991-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-10-15
LABELING; Labeling	SUPPL	20	AP	1990-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1991-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1994-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1994-02-08
LABELING; Labeling	SUPPL	24	AP	1994-02-08
LABELING; Labeling	SUPPL	25	AP	1993-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1994-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1995-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-09-05
LABELING; Labeling	SUPPL	32	AP	1997-07-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2000-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1998-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1998-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1998-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	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	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89689
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"650MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"650MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)