NDA 021393

GLAXOSMITHKLINE

FDA Drug Application

Application #021393

Documents

• Letter: 2006-01-19
• Letter: 2011-04-21
• Label: 2006-01-05
• Letter: 2008-06-16
• Letter: 2009-05-27
• Letter: 2013-03-21
• Label: 2013-03-22
• Review: 2006-09-07
• Letter: 2017-04-03
• Label: 2017-04-05
• Letter: 2018-05-10
• Label: 2018-05-23
• Label: 2022-01-12
• Letter: 2022-01-12

Application Sponsors

NDA 021393

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

1

ADVIL PM

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2005-12-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2008-06-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2009-05-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2011-04-20	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-02-04	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-03-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-05-07	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-01-11	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	12	Null	0
SUPPL	14	Null	7
SUPPL	17	Null	7
SUPPL	21	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21393
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL PM","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN","strength":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/07\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/21393Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021393Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2013","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021393Orig1s012lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"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 HYDROCHLORIDE; IBUPROFEN","actionType":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-07
        )

)