ANDA 075822

GLAXOSMITHKLINE

FDA Drug Application

Application #075822

Documents

• Review: 2007-05-09
• Letter: 2003-02-10

Application Sponsors

ANDA 075822

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

LORATADINE

LORATADINE

FDA Submissions

	ORIG	1	AP	2003-02-10
LABELING; Labeling	SUPPL	2	AP	2008-01-25

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75822
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORATADINE","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)