ANDA 089557

MIKART

FDA Drug Application

Application #089557

Documents

• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22
• Review: 2005-07-22

Application Sponsors

ANDA 089557

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	1992-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-01-18
LABELING; Labeling	SUPPL	3	AP	2000-08-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-08-13
S; Supplement	SUPPL	9	AP	2004-07-26

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89557
            [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
        )

)