ANDA 070288

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #070288

Application Sponsors

ANDA 070288

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

10GM/15ML

0

CONSTULOSE

LACTULOSE

FDA Submissions

	ORIG	1	AP	1988-08-15
LABELING; Labeling	SUPPL	9	AP	1991-08-21
LABELING; Labeling	SUPPL	12	AP	1990-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-09-28
LABELING; Labeling	SUPPL	15	AP	1991-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1991-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1993-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1996-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-12-16

Submissions Property Types

SUPPL	13	Null	0
SUPPL	14	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

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70288
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONSTULOSE","activeIngredients":"LACTULOSE","strength":"10GM\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CONSTULOSE","submission":"LACTULOSE","actionType":"10GM\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)