FDA.reportPublic FDA data

Application 020641

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLARITINLORATADINESYRUP;ORAL1MG/MLYesYes
003CLARITIN HIVES RELIEFLORATADINESYRUP;ORAL1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020641-002CLARITINLORATADINE1MG/MLSYRUP / ORALRLD, RS2002-11-27
N020641-003CLARITIN HIVES RELIEFLORATADINE1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD2003-11-19

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020641-002CLARITIN1MG/MLSYRUP / ORALRLD, RS2002-11-27f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020641-003CLARITIN HIVES RELIEF1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD2003-11-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020641-002CLARITIN1MG/MLSYRUP / ORALRLD, RS2002-11-27e64feba35796…
2022-09-29 23:25 UTC2022-09N020641-003CLARITIN HIVES RELIEF1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD2003-11-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020641-002CLARITIN1MG/MLSYRUP / ORALRLD, RS2002-11-27cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020641-003CLARITIN HIVES RELIEF1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD2003-11-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020641-002CLARITIN1MG/MLSYRUP / ORALRLD, RS2002-11-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020641-003CLARITIN HIVES RELIEF1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SYRUP / ORALRLD2003-11-19a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Claritin AllergyLORATADINEBayer HealthCare LLC.19afd658-8c67-af44-e063-6394a90abada2025-12-04WarningsExact identifier
application applno (NDA): 020641
application number: NDA020641
Children Claritin AllergyLORATADINEBayer HealthCare LLC.170061e9-e529-4ff0-e054-00144ff8d46c2025-05-15WarningsExact identifier
application applno (NDA): 020641
application number: NDA020641
ndc (product): 11523-4360

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent
11523-4360Children ClaritinloratadineBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80586SUPPL 2024-12-16
80585SUPPL 2024-12-16
57865SUPPL2019-03-01
57855SUPPL2019-03-01
54314SUPPL2018-05-23
54218SUPPL2018-05-16
45089SUPPL2016-08-22
45033SUPPL2016-08-09
12919SUPPL2016-01-04
2992SUPPL2015-12-31
35067SUPPL2015-11-25
2991SUPPL2015-11-09
35066SUPPL2015-10-26
25433SUPPL2015-10-23
2990SUPPL2015-04-22
12918SUPPL2015-04-21
35065SUPPL2014-01-14
2989SUPPL2013-03-01
25432SUPPL2008-07-30
25431SUPPL2008-07-30
41517SUPPL2007-03-02
20803SUPPL2007-03-02
2988SUPPL2005-06-15
41518SUPPL2004-12-07
2987SUPPL2004-10-29
25430SUPPL2004-07-21
25429SUPPL2003-11-25
25428SUPPL2002-11-27
20804SUPPL2000-12-04
12917SUPPL2000-12-04
2986SUPPL2000-12-04