ANDA 081226

MIKART

FDA Drug Application

Application #081226

Application Sponsors

ANDA 081226

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

500MG/15ML;5MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1992-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-08-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81226
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG\/15ML;5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG\/15ML;5MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)