NDA 022565

GLAXOSMITHKLINE

FDA Drug Application

Application #022565

Documents

• Label: 2015-04-14
• Review: 2010-09-23
• Letter: 2010-06-03
• Letter: 2015-04-02
• Summary Review: 2010-09-23
• Label: 2017-04-17
• Letter: 2017-04-18
• Letter: 2019-07-10
• Label: 2019-07-10
• Label: 2020-07-31
• Letter: 2020-07-31
• Letter: 2021-11-23
• Label: 2021-11-23

Application Sponsors

NDA 022565

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG;10MG

1

ADVIL CONGESTION RELIEF

IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2010-05-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2015-03-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-03-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-07-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-07-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	31
SUPPL	6	Null	6
SUPPL	9	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22565
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL CONGESTION RELIEF","activeIngredients":"IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","strength":"200MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"03\/24\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022565Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022565Orig1s002lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADVIL CONGESTION RELIEF","submission":"IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE","actionType":"200MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-09
        )

)