ANDA 078569

SUN PHARM INDS LTD

FDA Drug Application

Application #078569

Application Sponsors

ANDA 078569

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

650MG

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

	ORIG	1	AP	2011-12-14
LABELING; Labeling	SUPPL	4	AP	2015-08-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78569
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"650MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"650MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)