ANDA 089363

MIKART

FDA Drug Application

Application #089363

Application Sponsors

ANDA 089363

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

650MG;60MG

0

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1991-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89363
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; CODEINE PHOSPHATE","strength":"650MG;60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; CODEINE PHOSPHATE","actionType":"650MG;60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)