FDA.reportPublic FDA data

Application 020980

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMISILTERBINAFINE HYDROCHLORIDECREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-3998LamisilTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-3999LamisilTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
11673-401athletes footterbinafin hydrochlorideTarget CorporationNDACurrent
61047-120Lamisil AT CreamTerbinafine HydrochlorideKIK HOLDCO COMPANY INC.NDACurrent
61047-120Lamisil AT CreamTerbinafine HydrochlorideVoyant Beauty Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59375SUPPL2019-07-18
59374SUPPL2019-07-18
3928SUPPL2012-03-26
26370SUPPL2007-07-27
14078SUPPL2007-07-27
26369ORIG2004-06-08
41859ORIG1999-03-10