NDA 021441

GLAXOSMITHKLINE

FDA Drug Application

Application #021441

Documents

• Letter: 2004-07-14
• Letter: 2006-03-01
• Letter: 2010-09-07
• Letter: 2004-05-26
• Letter: 2008-06-24
• Letter: 2009-05-27
• Label: 2003-04-09
• Label: 2004-07-14
• Review: 2004-04-21
• Label: 2017-04-17
• Letter: 2017-04-18
• Letter: 2021-11-24
• Label: 2021-11-30

Application Sponsors

NDA 021441

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

2MG;200MG;30MG

1

ADVIL ALLERGY SINUS

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2002-12-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2006-02-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2008-06-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	2009-05-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2010-08-31	UNKNOWN
LABELING; Labeling	SUPPL	12	AP	2017-03-24	STANDARD
LABELING; Labeling	SUPPL	16	AP	2021-11-23	STANDARD

Submissions Property Types

SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	16	Null	6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21441
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL ALLERGY SINUS","activeIngredients":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"2MG;200MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021441Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2004","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21441slr001_advil_lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21441_Advil_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADVIL ALLERGY SINUS","submission":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"2MG;200MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-24
        )

)