NDA 021374

GLAXOSMITHKLINE

FDA Drug Application

Application #021374

Documents

• Letter: 2003-10-22
• Letter: 2009-05-27
• Label: 2003-10-22
• Letter: 2002-05-30
• Letter: 2006-04-20
• Letter: 2005-12-15
• Letter: 2008-06-24
• Letter: 2011-03-16
• Label: 2002-05-30
• Review: 2004-05-26
• Label: 2017-04-03
• Letter: 2017-04-03
• Letter: 2021-11-23
• Label: 2021-11-23

Application Sponsors

NDA 021374

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

1

ADVIL COLD AND SINUS

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-05-30	STANDARD
LABELING; Labeling	SUPPL	4	AP	2006-04-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-12-07	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-06-23	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-05-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2011-03-14	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2017-03-24	STANDARD
LABELING; Labeling	SUPPL	14	AP	2021-11-19	STANDARD

Submissions Property Types

SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	14	Null	6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21374
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL COLD AND SINUS","activeIngredients":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/24\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021374Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2003","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21374SLR001_Advil_lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21374lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADVIL COLD AND SINUS","submission":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"EQ 200MG FREE ACID AND POTASSIUM SALT;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-24
        )

)