ANDA 076050

PERRIGO PHARMA INTL

FDA Drug Application

Application #076050

Documents

• Review: 2012-03-28
• Letter: 2004-06-08

Application Sponsors

ANDA 076050

PERRIGO PHARMA INTL

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

5MG;120MG

0

LORATADINE AND PSEUDOEPHEDRINE SULFATE

LORATADINE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

	ORIG	1	AP	2003-01-30
LABELING; Labeling	SUPPL	5	AP	2004-07-28
LABELING; Labeling	SUPPL	7	AP	2004-09-22
LABELING; Labeling	SUPPL	11	AP	2005-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-10-21

Submissions Property Types

SUPPL

21

Null

0

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76050
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE AND PSEUDOEPHEDRINE SULFATE","activeIngredients":"LORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"5MG;120MG","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":"5MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)