Mupirocin Nasal Ointment

Brand(s)
Bactroban
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2015-09-22)
Oldest Current Product
1996-04-10
License(s)
NDA
RxNORM
NASAL OINTMENT\MUPIROCIN
FDAOB
NASAL\OINTMENT\MUPIROCIN CALCIUM
SPL Active
TOPICAL\OINTMENT\MUPIROCIN CALCIUM
SPL Moiety
TOPICAL\OINTMENT\MUPIROCIN

product(s) by strength(s)

mupirocin 0.02 mg/mg nasal ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000291526BactrobanNDAGlaxosmithkline Llc1996-04-10MUPIROCIN CALCIUMTOPICALOINTMENTNDA0507038f44a933-1629-4e65-16a6-9ad421329aa6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560468BactrobanNDALake Erie Medical Dba Quality Care Products Llc1996-04-10MUPIROCIN CALCIUMTOPICALOINTMENT000291526NDA05070337db99f0-b4b4-42a5-9af5-d1ff8c821da9
2548684325BactrobanNDAPhysicians Total Care, Inc.1996-04-10MUPIROCIN CALCIUMTOPICALOINTMENT000291526NDA050703b5777cde-7cd5-4fc8-a5a1-0ef4ddf6b5b1
3551544522BactrobanNDACardinal Health1996-04-10MUPIROCIN CALCIUMTOPICALOINTMENT000291526NDA050703c142ab8f-fa5c-471a-a49a-058ab8ec023b

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050703BACTROBANGLAXOSMITHKLINE1995-09-18NDA050703_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050703_001RXMUPIROCIN CALCIUM (EQ 2% BASE)NASALOINTMENTTrue1995-09-18BACTROBAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
137db99f0-b4b4-42a5-9af5-d1ff8c821da9 (view SPL)These highlights do not include all the information needed to use BACTROBAN Nasal Ointment safely and effectively. See full prescribing information for BACTROBAN Nasal Ointment.BACTROBAN (mupirocin calcium) nasal ointment) Initial U.S. Approval: 1995prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-10-131353560468
28f44a933-1629-4e65-16a6-9ad421329aa6 (view SPL)These highlights do not include all the information needed to use BACTROBAN Nasal Ointment safely and effectively. See full prescribing information for BACTROBAN Nasal Ointment.BACTROBAN (mupirocin calcium) nasal ointment Initial U.S. Approval: 1995prescriptionHuman PrescriptionGlaxosmithkline Llc2015-09-2211000291526
3b5777cde-7cd5-4fc8-a5a1-0ef4ddf6b5b1 (view SPL)BACTROBAN NASAL (mupirocin calcium ointment, 2%)for intranasal use onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-10-242548684325
4c142ab8f-fa5c-471a-a49a-058ab8ec023b (view SPL)BACTROBAN NASAL ( mupirocin calcium ointment, 2%) for intranasal use onlyprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-081551544522

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII