NDA 017129

MALLINCKRODT

FDA Drug Application

Application #017129

Application Sponsors

NDA 017129

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG

0

CHOLEBRINE

IOCETAMIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1973-05-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	1997-08-25
LABELING; Labeling	SUPPL	6	AP	1997-08-25

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17129
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHOLEBRINE","activeIngredients":"IOCETAMIC ACID","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHOLEBRINE","submission":"IOCETAMIC ACID","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)