FDA.reportPublic FDA data

Application 076707

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET; ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET; ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDETABLET; ORAL180MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limitede0537b71-fdee-4122-9c09-868ce73520802026-06-15WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEYYBA Corp53fe8ef5-ab65-f23e-e063-6394a90a30f02026-06-11WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEYYBA Corp53e87aa4-9db3-9ded-e063-6294a90a319e2026-06-10WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEGrocery Outlet, Inc.441ce66e-515a-d380-e063-6394a90aec7d2026-05-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLC895de6e9-c5b6-42fe-b450-f5d8331ce2e32026-05-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEOHM LABORATORIES INC.1a1afa95-570d-456e-b436-a0fcfaf685172026-05-05WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Allergy, Travel BASIXFEXOFENADINE HYDROCHLORIDELil' Drug Store Products, Incb82d993a-16ff-4037-a182-7010de8e1cdd2026-04-27WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra AllergyFEXOFENADINE HYDROCHLORIDENavajo Manufacturing Company Inc.e8a00fa1-79af-4ce6-885f-0ce12c5da8362026-04-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Goodmeds Non Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.ae1322f5-85d6-4243-b384-2ce7f8c8d6922026-04-20WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
careone allergy reliefFEXOFENADINE HYDROCHLORIDERetail Business Services, LLCce398856-e9a6-401d-8636-bc5771a7e28b2026-04-14WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd1732026-04-14WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
allergy reliefFEXOFENADINE HYDROCHLORIDEHyVee Inc54635220-dd44-4baa-b929-9e52deb4c3682026-03-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORP2dd5e6b0-2445-4419-b0e6-c62aadee6ea42026-03-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
berkley jensen allergy reliefFEXOFENADINE HYDROCHLORIDEBJWC2c6d9f8c-bc74-4e1a-bd51-50f84ab63a152026-02-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Nuvicare Hives ReliefFEXOFENADINE HYDROCHLORIDENUVICARE LLCa8e11094-ca69-488d-a720-b8129f17f5052026-01-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Gencare Hives ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCad0944f1-c5af-42cf-96c9-3140cbda66d82026-01-21WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHYVEE INC3e61ffb1-1c52-1ad5-e063-6294a90a6e3f2026-01-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.e2bd23c7-dfba-463a-adbe-2183970da7402026-01-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra Hives 24hrFEXOFENADINE HYDROCHLORIDEChattem, Inc.490b4c5f-448b-4563-928b-837117b59b9f2026-01-12WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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