ANDA 076557

SUN PHARM INDS LTD

FDA Drug Application

Application #076557

Documents

• Review: 2011-02-15

Application Sponsors

ANDA 076557

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG;240MG

0

LORATADINE AND PSEUDOEPHEDRINE SULFATE

LORATADINE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

	ORIG	1	AP	2004-09-22
LABELING; Labeling	SUPPL	2	AP	2005-04-13
LABELING; Labeling	SUPPL	6	AP	2005-09-20
LABELING; Labeling	SUPPL	15	AP	2010-06-29

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76557
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE AND PSEUDOEPHEDRINE SULFATE","activeIngredients":"LORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"10MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORATADINE AND PSEUDOEPHEDRINE SULFATE","submission":"LORATADINE; PSEUDOEPHEDRINE SULFATE","actionType":"10MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)