NDA 050591

GLAXOSMITHKLINE

FDA Drug Application

Application #050591

Documents

• Letter: 2014-05-27
• Review: 2002-07-12
• Letter: 1999-04-22
• Letter: 2015-03-20
• Label: 2015-03-20
• Label: 2014-05-28
• Label: 2015-12-15
• Label: 2017-05-09
• Letter: 2017-05-10

Application Sponsors

NDA 050591

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

BACTROBAN

MUPIROCIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-12-31	STANDARD
LABELING; Labeling	SUPPL	9	AP	1991-04-15
LABELING; Labeling	SUPPL	10	AP	1991-04-15
LABELING; Labeling	SUPPL	11	AP	1991-04-15
LABELING; Labeling	SUPPL	12	AP	1991-09-30
LABELING; Labeling	SUPPL	13	AP	1991-04-15
LABELING; Labeling	SUPPL	15	AP	1996-02-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-12-03	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1999-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2001-11-09	STANDARD
LABELING; Labeling	SUPPL	30	AP	2015-03-19	STANDARD
LABELING; Labeling	SUPPL	32	AP	2014-05-22	STANDARD
LABELING; Labeling	SUPPL	33	AP	2015-12-14	STANDARD
LABELING; Labeling	SUPPL	34	AP	2017-05-08	STANDARD

Submissions Property Types

SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	30	Null	6
SUPPL	32	Null	6
SUPPL	33	Null	6
SUPPL	34	Null	33

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50591
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTROBAN","activeIngredients":"MUPIROCIN","strength":"2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/08\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050591s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2015","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050591s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2015","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050591s030lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050591s032,050703s015,050746s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BACTROBAN","submission":"MUPIROCIN","actionType":"2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-05-08
        )

)