NDA 021394

GLAXOSMITHKLINE

FDA Drug Application

Application #021394

Documents

• Letter: 2009-05-27
• Review: 2006-09-07
• Letter: 2006-01-19
• Letter: 2008-06-13
• Letter: 2011-04-28
• Letter: 2010-09-07
• Label: 2006-01-05
• Letter: 2017-04-03
• Label: 2017-04-05
• Letter: 2017-07-25
• Label: 2017-07-26
• Letter: 2018-04-20
• Label: 2018-04-23
• Label: 2018-10-15
• Letter: 2018-10-26
• Label: 2022-01-11
• Letter: 2022-01-11

Application Sponsors

NDA 021394

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

38MG;200MG

1

ADVIL PM

DIPHENHYDRAMINE CITRATE; IBUPROFEN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2005-12-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2008-06-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	2009-05-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2011-04-25	STANDARD
LABELING; Labeling	SUPPL	15	AP	2010-09-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2015-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2015-01-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2016-03-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-03-30	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-07-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	26	AP	2018-10-02	STANDARD
LABELING; Labeling	SUPPL	32	AP	2022-01-10	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	15	Null	6
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	6
SUPPL	23	Null	15
SUPPL	25	Null	6
SUPPL	26	Null	6
SUPPL	32	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21394
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL PM","activeIngredients":"DIPHENHYDRAMINE CITRATE; IBUPROFEN","strength":"38MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/02\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021394Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021394Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021394Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021394Orig1s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021393,021394lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADVIL PM","submission":"DIPHENHYDRAMINE CITRATE; IBUPROFEN","actionType":"38MG;200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-10-02
        )

)