ANDA 040676

MIKART

FDA Drug Application

Application #040676

Application Sponsors

ANDA 040676

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG;10MG

0

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2006-04-19

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40676
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"500MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"500MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)