ANDA 089405

MALLINCKRODT

FDA Drug Application

Application #089405

Application Sponsors

ANDA 089405

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

650MG;50MG

0

TENCON

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

	ORIG	1	AP	1990-05-15
LABELING; Labeling	SUPPL	2	AP	1991-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-05-05
LABELING; Labeling	SUPPL	4	AP	1992-04-16
LABELING; Labeling	SUPPL	5	AP	1994-02-16
LABELING; Labeling	SUPPL	6	AP	1994-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-08-30
LABELING; Labeling	SUPPL	9	AP	1996-11-14

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	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

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89405
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENCON","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"650MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TENCON","submission":"ACETAMINOPHEN; BUTALBITAL","actionType":"650MG;50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)