ANDA 088790

JANSSEN PHARMS

FDA Drug Application

Application #088790

Application Sponsors

ANDA 088790

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

500MG;5MG

0

TYLOX

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-12-12
LABELING; Labeling	SUPPL	8	AP	1991-05-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-01-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-11-30

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88790
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TYLOX","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TYLOX","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)