NDA 050703

GLAXOSMITHKLINE

FDA Drug Application

Application #050703

Documents

• Letter: 2014-05-27
• Letter: 2015-05-19
• Label: 2015-05-21
• Label: 2014-05-28
• Label: 2017-05-09
• Letter: 2017-05-10
• Letter: 2020-02-20
• Label: 2020-02-19

Application Sponsors

NDA 050703

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;NASAL

EQ 2% BASE

1

BACTROBAN

MUPIROCIN CALCIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1995-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-11-15	STANDARD
LABELING; Labeling	SUPPL	15	AP	2014-05-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-05-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	2017-05-08	STANDARD
LABELING; Labeling	SUPPL	18	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	15	Null	15
SUPPL	16	Null	6
SUPPL	17	Null	33
SUPPL	18	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50703
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTROBAN","activeIngredients":"MUPIROCIN CALCIUM","strength":"EQ 2% BASE","dosageForm":"OINTMENT;NASAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/19\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050703s018lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2020","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050703s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/050703s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050703s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2014","submission":"SUPPL-15","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","submissionClassification":"OINTMENT;NASAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-02-19
        )

)