ANDA 089988

MIKART

FDA Drug Application

Application #089988

Application Sponsors

ANDA 089988

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG;50MG

0

BUTAPAP

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

	ORIG	1	AP	1992-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-02-08
LABELING; Labeling	SUPPL	4	AP	2000-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89988
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTAPAP","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"650MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTAPAP","submission":"ACETAMINOPHEN; BUTALBITAL","actionType":"650MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)