ANDA 040508

MALLINCKRODT INC

FDA Drug Application

Application #040508

Application Sponsors

ANDA 040508

MALLINCKRODT INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

500MG/15ML;10MG/15ML

0

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG

1

AP

2003-08-29

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MALLINCKRODT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40508
            [companyName] => MALLINCKRODT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG\/15ML;10MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG\/15ML;10MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)