NDA 050746

GLAXOSMITHKLINE

FDA Drug Application

Application #050746

Documents

• Letter: 2015-03-20
• Letter: 2014-05-27
• Label: 2014-05-28
• Label: 2015-12-15
• Letter: 2015-12-15
• Label: 2015-03-20
• Review: 2003-08-08
• Label: 2017-05-09
• Letter: 2017-05-10
• Letter: 2020-02-20
• Label: 2020-02-20

Application Sponsors

NDA 050746

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

BACTROBAN

MUPIROCIN CALCIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-09-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-11-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-03-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-12-14	STANDARD
LABELING; Labeling	SUPPL	21	AP	2017-05-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-02-19	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	0
SUPPL	20	Null	6
SUPPL	21	Null	6
SUPPL	22	Null	6

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50746
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTROBAN","activeIngredients":"MUPIROCIN CALCIUM","strength":"EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/19\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050746s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2020","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050746s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050746s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050746s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2015","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050746s013lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-18","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 CALCIUM","actionType":"EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-02-19
        )

)