ANDA 089987

MIKART

FDA Drug Application

Application #089987

Application Sponsors

ANDA 089987

MIKART

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

325MG;50MG

0

BUTAPAP

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

	ORIG	1	AP	1992-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-13
LABELING; Labeling	SUPPL	5	AP	2000-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-08-13
LABELING; Labeling	SUPPL	14	AP	2011-06-22
LABELING; Labeling	SUPPL	15	AP	2013-10-18	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	7
SUPPL	15	Null	7

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89987
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTAPAP","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"325MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTAPAP","submission":"ACETAMINOPHEN; BUTALBITAL","actionType":"325MG;50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)