ANDA 074138

VISTAPHARM

FDA Drug Application

Application #074138

Application Sponsors

ANDA 074138

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

10GM/15ML

0

LACTULOSE

LACTULOSE

FDA Submissions

	ORIG	1	AP	1992-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-08-07
LABELING; Labeling	SUPPL	5	AP	1996-08-07
LABELING; Labeling	SUPPL	6	AP	1996-09-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-01-31
LABELING; Labeling	SUPPL	8	AP	1997-01-31
LABELING; Labeling	SUPPL	9	AP	1998-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-11-28

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

TE Codes

001

Prescription

AA

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74138
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACTULOSE","activeIngredients":"LACTULOSE","strength":"10GM\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LACTULOSE","submission":"LACTULOSE","actionType":"10GM\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)