ANDA 040100

UCB INC

FDA Drug Application

Application #040100

Application Sponsors

ANDA 040100

UCB INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG;10MG

0

LORTAB

ACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

	ORIG	1	AP	1996-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-01-03
LABELING; Labeling	SUPPL	3	AP	1997-01-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-08-03

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40100
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORTAB","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORTAB","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)