ANDA 040468

MALLINCKRODT

FDA Drug Application

Application #040468

Application Sponsors

ANDA 040468

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG;10MG

0

ANEXSIA

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	2002-10-31
LABELING; Labeling	SUPPL	7	AP	2011-06-24

Submissions Property Types

ORIG	1	Null	0
SUPPL	7	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40468
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANEXSIA","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"750MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANEXSIA","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"750MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)