ANDA 077153

SUN PHARM INDS LTD

FDA Drug Application

Application #077153

Application Sponsors

ANDA 077153

SUN PHARM INDS LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

LORATADINE REDIDOSE

LORATADINE

FDA Submissions

	ORIG	1	AP	2007-04-11
LABELING; Labeling	SUPPL	6	AP	2014-01-26
LABELING; Labeling	SUPPL	10	AP	2020-03-03	STANDARD

Submissions Property Types

SUPPL	6	Null	15
SUPPL	10	Null	7

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77153
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE REDIDOSE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORATADINE REDIDOSE","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)