ANDA 079239

SUN PHARM INDS INC

FDA Drug Application

Application #079239

Application Sponsors

ANDA 079239

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

600MG

0

GEMFIBROZIL

GEMFIBROZIL

FDA Submissions

	ORIG	1	AP	2008-12-29
LABELING; Labeling	SUPPL	4	AP	2009-12-15
LABELING; Labeling	SUPPL	7	AP	2011-09-27
LABELING; Labeling	SUPPL	9	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-06-04	STANDARD

Submissions Property Types

SUPPL	4	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79239
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMFIBROZIL","activeIngredients":"GEMFIBROZIL","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GEMFIBROZIL","submission":"GEMFIBROZIL","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)