ANDA 089238

MIKART

FDA Drug Application

Application #089238

Application Sponsors

ANDA 089238

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

300MG;30MG

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1986-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-06-04
LABELING; Labeling	SUPPL	3	AP	1991-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-07-20
LABELING; Labeling	SUPPL	12	AP	1995-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	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	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89238
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"300MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"300MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)