ANDA 088991

MALLINCKRODT

FDA Drug Application

Application #088991

Application Sponsors

ANDA 088991

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

650MG;50MG

0

BUCET

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

	ORIG	1	AP	1985-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-02-07
LABELING; Labeling	SUPPL	7	AP	1989-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-04-08
LABELING; Labeling	SUPPL	10	AP	1989-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-08-18
LABELING; Labeling	SUPPL	12	AP	1989-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-02-27
LABELING; Labeling	SUPPL	14	AP	1992-03-20
LABELING; Labeling	SUPPL	15	AP	1994-04-12
LABELING; Labeling	SUPPL	16	AP	1994-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-08-30

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88991
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUCET","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"650MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUCET","submission":"ACETAMINOPHEN; BUTALBITAL","actionType":"650MG;50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)