FDA.reportPublic FDA data

Application 021124

Type
NDA
Sponsor
GLAXOSMITHKLINE CONS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMISIL ATTERBINAFINE HYDROCHLORIDESOLUTION;TOPICAL1%YesYes
002LAMISIL ATTERBINAFINE HYDROCHLORIDESPRAY;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-6292LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6292LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6293LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer NDACurrent
0067-6296LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6296LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6296LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6297LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6297LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0067-6297LAMISILTERBINAFINE HYDROCHLORIDEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56098SUPPL2018-10-26
56068SUPPL2018-10-23
36163SUPPL2013-11-19
4389SUPPL2013-11-15
4388SUPPL2012-03-26
4387SUPPL2010-02-22
4386SUPPL2009-06-17
26833SUPPL2008-07-31
41965ORIG2002-05-15
14442ORIG2000-03-17
4385ORIG2000-03-17