FDA.reportPublic FDA data

Application 050746

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACTROBANMUPIROCIN CALCIUMCREAM;TOPICALEQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0029-1527BACTROBANmupirocin calciumGlaxoSmithKline LLCNDACurrent
0029-1527BACTROBANmupirocin calciumGlaxoSmithKline LLCNDACurrent
0029-1527BACTROBANmupirocin calciumGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61925SUPPL2020-02-20
61923SUPPL2020-02-20
48346SUPPL2017-05-10
48314SUPPL2017-05-09
30428SUPPL2015-12-15
18162SUPPL2015-12-15
39235SUPPL2015-03-20
8165SUPPL2015-03-20
18161SUPPL2014-05-28
8166SUPPL2014-05-27
42714ORIG2003-08-08