FDA.reportPublic FDA data

Application 021375

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALAVERTLORATADINETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0573-2620ALAVERT ALLERGYloratadineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2620ALAVERT ALLERGYloratadineWyeth Consumer Healthcare LLCNDACurrent
0573-2620ALAVERT ALLERGYloratadineWyeth Consumer Healthcare LLCNDACurrent
0573-2621ALAVERT ALLERGYloratadineGlaxoSmithKline Consumer Healthcare Holdings (US) LLCNDACurrent
0573-2621ALAVERT ALLERGYloratadineWyeth Consumer Healthcare LLCNDACurrent
0573-2621ALAVERT ALLERGYloratadineWyeth Consumer Healthcare LLCNDACurrent
80070-110AlavertLORATADINEFoundation Consumer BrandsNDACurrent
80070-120AlavertLORATADINEFoundation Consumer BrandsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
27639SUPPL2005-08-23
5224ORIG2004-05-26
42129ORIG2004-03-24
36796ORIG2003-04-09