ANDA 040201

MALLINCKRODT

FDA Drug Application

Application #040201

Documents

• Review: 1998-02-27

Application Sponsors

ANDA 040201

MALLINCKRODT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	500MG;7.5MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE
002	TABLET;ORAL	500MG;10MG	0	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1998-02-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-04-25
LABELING; Labeling	SUPPL	6	AP	2000-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-08-05
LABELING; Labeling	SUPPL	9	AP	2002-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-09-27
LABELING; Labeling	SUPPL	11	AP	2002-11-13
LABELING; Labeling	SUPPL	29	AP	2011-06-24

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
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	29	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40201
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)