ANDA 075989

PERRIGO PHARMA INTL

FDA Drug Application

Application #075989

Documents

• Review: 2004-03-04

Application Sponsors

ANDA 075989

PERRIGO PHARMA INTL

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	2004-03-04
LABELING; Labeling	SUPPL	9	AP	2009-03-27

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75989
            [companyName] => PERRIGO PHARMA INTL
            [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
        )

)