FDA.reportPublic FDA data

Application 021375

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021375-001ALAVERTLORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021375-001ALAVERT10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alavert AllergyLORATADINEFoundation Consumer Brands039ea563-9796-4270-b84a-50dd25a9d9762026-02-23WarningsExact identifier
application applno (NDA): 021375
application number: NDA021375
ndc (product): 80070-120
Alavert AllergyLORATADINEFoundation Consumer Brandsf741d1cf-0ecb-4405-8596-07af394537db2026-02-23WarningsExact identifier
application applno (NDA): 021375
application number: NDA021375
ndc (product): 80070-110

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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