ANDA 087388

LIEBEL-FLARSHEIM

FDA Drug Application

Application #087388

Application Sponsors

ANDA 087388

LIEBEL-FLARSHEIM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL, RECTAL

66%;10%

0

MD-GASTROVIEW

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

FDA Submissions

	ORIG	1	AP	1981-09-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-02-27
LABELING; Labeling	SUPPL	11	AP	2004-07-13
LABELING; Labeling	SUPPL	12	AP	2004-07-13
LABELING; Labeling	SUPPL	14	AP	2007-04-26
LABELING; Labeling	SUPPL	16	AP	2009-06-30
LABELING; Labeling	SUPPL	17	AP	2009-09-28
LABELING; Labeling	SUPPL	18	AP	2009-09-28

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	17	Null	7
SUPPL	18	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LIEBEL-FLARSHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87388
            [companyName] => LIEBEL-FLARSHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MD-GASTROVIEW","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"66%;10%","dosageForm":"SOLUTION;ORAL, RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MD-GASTROVIEW","submission":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","actionType":"66%;10%","submissionClassification":"SOLUTION;ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)