ANDA 088758

MALLINCKRODT

FDA Drug Application

Application #088758

Application Sponsors

ANDA 088758

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	1985-03-27
LABELING; Labeling	SUPPL	19	AP	1988-06-03
LABELING; Labeling	SUPPL	23	AP	1992-03-20
LABELING; Labeling	SUPPL	25	AP	1994-04-13

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88758
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)