NDA 021587

GLAXOSMITHKLINE

FDA Drug Application

Application #021587

Documents

• Label: 2004-03-03
• Review: 2005-04-27
• Letter: 2004-02-25
• Letter: 2006-04-07
• Label: 2017-04-05

Application Sponsors

NDA 021587

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION;ORAL

1MG/5ML;100MG/5ML;15MG/5ML

1

CHILDREN'S ADVIL ALLERGY SINUS

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-02-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2006-04-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-03-24	STANDARD

Submissions Property Types

SUPPL

6

Null

6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21587
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S ADVIL ALLERGY SINUS","activeIngredients":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"1MG\/5ML;100MG\/5ML;15MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021587Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21587_childrens_advil.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CHILDREN'S ADVIL ALLERGY SINUS","submission":"CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"1MG\/5ML;100MG\/5ML;15MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-24
        )

)