NDA 201803

GLAXOSMITHKLINE

FDA Drug Application

Application #201803

Documents

• Letter: 2016-06-07
• Review: 2012-11-29
• Letter: 2012-06-14
• Label: 2012-08-30
• Label: 2016-06-10
• Summary Review: 2012-11-29
• Letter: 2017-06-13
• Label: 2017-06-14
• Label: 2017-08-24
• Letter: 2017-08-25
• Letter: 2018-04-16
• Label: 2018-04-23
• Letter: 2018-06-01
• Label: 2018-06-01
• Letter: 2022-02-09
• Label: 2022-02-09

Application Sponsors

NDA 201803

GLAXOSMITHKLINE

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE

1

ADVIL

IBUPROFEN SODIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2012-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-01-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-11-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-06-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2017-06-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-08-22	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-04-12	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-05-31	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-02-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	16	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201803
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADVIL","activeIngredients":"IBUPROFEN SODIUM","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/31\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201803Orig1s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201803Orig1s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201803Orig1s009lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201803Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201803Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201803Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/12\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201803Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201803s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201803_advil_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201803Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/31\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201803Orig1s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201803Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"04\/12\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201803Orig1s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201803Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"08\/22\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201803Orig1s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201803Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"06\/12\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201803Orig1s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201803Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"06\/03\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201803Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201803Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/05\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/03\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/15\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-31
        )

)