NDA 021373

GLAXOSMITHKLINE

FDA Drug Application

Application #021373

Documents

• Letter: 2006-04-07
• Letter: 2008-12-11
• Letter: 2009-05-27
• Label: 2002-04-18
• Letter: 2002-04-18
• Letter: 2004-06-01
• Letter: 2005-01-13
• Letter: 2010-08-26
• Review: 2002-04-18
• Label: 2017-04-05
• Letter: 2017-04-05

Application Sponsors

NDA 021373

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML;15MG/5ML

0

CHILDREN'S ADVIL COLD

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-04-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2005-01-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2006-04-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-12-03	STANDARD
LABELING; Labeling	SUPPL	9	AP	2009-05-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2010-08-24	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2012-12-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2017-03-24	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	0
SUPPL	13	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21373
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S ADVIL COLD","activeIngredients":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"100MG\/5ML;15MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/24\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021373Orig1s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21373lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CHILDREN'S ADVIL COLD","submission":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"100MG\/5ML;15MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-03-24
        )

)