ANDA 071548

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #071548

Application Sponsors

ANDA 071548

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL, RECTAL

10GM/15ML

0

ENULOSE

LACTULOSE

FDA Submissions

	ORIG	1	AP	1988-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-10-16
LABELING; Labeling	SUPPL	13	AP	1990-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1993-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-08-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-08-07
LABELING; Labeling	SUPPL	38	AP	2009-12-20

Submissions Property Types

SUPPL	2	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0

TE Codes

001

Prescription

AA

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71548
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENULOSE","activeIngredients":"LACTULOSE","strength":"10GM\/15ML","dosageForm":"SOLUTION;ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENULOSE","submission":"LACTULOSE","actionType":"10GM\/15ML","submissionClassification":"SOLUTION;ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)