FDA.reportPublic FDA data

Application 021993

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITIN REDITABSLORATADINETABLET, ORALLY DISINTEGRATING;ORAL5MGYesYes

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
N021993-001CLARITIN REDITABSLORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2006-12-12

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 UTC2022-10N021993-001CLARITIN REDITABS5MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2006-12-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021993-001CLARITIN REDITABS5MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2006-12-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021993-001CLARITIN REDITABS5MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2006-12-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021993-001CLARITIN REDITABS5MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2006-12-12a50c72e98297…

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
Claritin ReditabsLORATADINEBayer HealthCare LLC7dc04b48-f053-4e4b-a493-9e8286d2a7912025-12-05WarningsExact identifier
application applno (NDA): 021993
application number: NDA021993
ndc (product): 11523-7202

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent
11523-7202ClaritinLoratadineBayer HealthCare LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74407SUPPL 2023-05-30
74377SUPPL 2023-05-26
57867SUPPL2019-03-01
57857SUPPL2019-03-01
55107SUPPL2018-08-03
54971SUPPL2018-07-25
38030SUPPL2015-12-01
29007SUPPL2015-11-27
38029SUPPL2014-07-29
6625SUPPL2014-07-24
6624SUPPL2008-10-23
42372ORIG2008-10-03
38028ORIG2006-12-14
29006ORIG2006-12-14