ANDA 090205

SUN PHARM INDS LTD

FDA Drug Application

Application #090205

Application Sponsors

ANDA 090205

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

650MG

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

	ORIG	1	AP	2009-11-18
LABELING; Labeling	SUPPL	2	AP	2014-12-13
LABELING; Labeling	SUPPL	3	AP	2015-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90205
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"650MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN","submission":"ACETAMINOPHEN","actionType":"650MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)