ANDA 076134

SUN PHARM INDS LTD

FDA Drug Application

Application #076134

Documents

• Letter: 2003-04-16
• Review: 2012-03-28

Application Sponsors

ANDA 076134

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

10MG

0

LORATADINE

LORATADINE

FDA Submissions

	ORIG	1	AP	2003-08-18
LABELING; Labeling	SUPPL	8	AP	2007-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2007-03-23
LABELING; Labeling	SUPPL	19	AP	2009-03-24

Submissions Property Types

SUPPL

15

Null

0

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76134
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORATADINE","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)