ANDA 081068

MIKART

FDA Drug Application

Application #081068

Application Sponsors

ANDA 081068

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	1989-11-30
LABELING; Labeling	SUPPL	2	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	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

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81068
            [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
        )

)