ANDA 081097

MIKART

FDA Drug Application

Application #081097

Application Sponsors

ANDA 081097

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

150MG;180MG;60MG

0

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1990-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-02-27
LABELING; Labeling	SUPPL	3	AP	1992-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-07-31

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81097
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","strength":"150MG;180MG;60MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","actionType":"150MG;180MG;60MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)