ANDA 087336

MALLINCKRODT

FDA Drug Application

Application #087336

Application Sponsors

ANDA 087336

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

500MG;5MG

0

LORCET-HD

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1982-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-02-22
LABELING; Labeling	SUPPL	12	AP	1988-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-07-15
LABELING; Labeling	SUPPL	17	AP	1994-08-15
LABELING; Labeling	SUPPL	18	AP	1988-09-19
LABELING; Labeling	SUPPL	19	AP	1989-09-07
LABELING; Labeling	SUPPL	20	AP	1989-09-22
LABELING; Labeling	SUPPL	21	AP	1989-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1991-12-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1994-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-06-05
LABELING; Labeling	SUPPL	26	AP	1995-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-07-20

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87336
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORCET-HD","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORCET-HD","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)