NDA 021375

GLAXOSMITHKLINE

FDA Drug Application

Application #021375

Documents

• Letter: 2004-05-26
• Letter: 2005-08-23
• Label: 2003-04-09
• Review: 2004-03-24

Application Sponsors

NDA 021375

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

ALAVERT

LORATADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2005-08-19	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21375
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALAVERT","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/19\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/021375lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALAVERT","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-12-19
        )

)