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 44.

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021375-001ALAVERT10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021375-001ALAVERT10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021375-001ALAVERT10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021375-001ALAVERT10MGTABLET, ORALLY DISINTEGRATING / ORAL2002-12-19a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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