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 3 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAMZ789 LLC1e46343f-d6b6-73ba-e063-6394a90acd942026-01-07WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS Pharmacy7cac266a-4de8-4af1-8324-b01823a3989a2026-01-07WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HClFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.f9ccd673-c65f-45c6-9863-26136eb816db2026-01-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HCLNorthwind Health Company, LLCf2b6c157-1af1-8d43-e053-2995a90aaf1a2026-01-01WarningsName fallback
brand name: Fexofenadine Hydrochloride
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCd7fe71e4-aada-40f5-86a8-bf0d7eb9b8512025-12-26WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLC0a4f4178-bea5-4995-99dc-96980cccdc8a2025-12-26WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
topcare allergy reliefFEXOFENADINE HYDROCHLORIDETopco Associates LLCe7658b5f-2d78-4f25-b1a3-e49198ca8f322025-12-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENUVICARE LLCbb47b839-3f49-4818-a62c-b6d2b09b15dc2025-12-19WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPa1e80757-346f-4d88-8da7-55583c3a902b2025-11-26WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief FexofenadineFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.9ed710e1-47f4-4d04-a509-12c8c97c192c2025-11-05WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
ValuMeds 24-Hour Allergy ReliefFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.036f8eaa-7eb9-46f4-b42e-3c8c7e49e4502025-10-23WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Cabinet Allergy Relief FexofenadineFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.5237c8bd-0b20-4639-a740-f3001c4c2c942025-10-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
CVS Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Pharmacy3d6c7b10-ed05-bbde-e063-6294a90ae92f2025-10-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
good sense aller easeFEXOFENADINE HYDROCHLORIDEL. Perrigo Companye533a008-b437-401e-ab50-bda31e6662d32025-10-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
up and up non drowsy allergy reliefFEXOFENADINE HYDROCHLORIDETarget Corporationd251b0a6-bc31-45b6-aaa8-f50f8336d9592025-08-19WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Non-Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDETARGET CORPORATION3cf4b7fe-b1f7-b767-430a-655408f917532025-08-01WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HCLMajor Pharmaceuticalsc34cda59-8a63-48ab-a19d-c06a1878f5da2025-07-18WarningsName fallback
brand name: Fexofenadine Hydrochloride
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEWalgreens Companyb961985e-0c18-b36f-d82e-32ff2d46fada2025-07-18WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERb72c4802-1bcb-48bc-b4b9-72167ea4643e2025-06-12WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDEWalgreens Company374f9271-b65b-69a9-e063-6394a90af36a2025-06-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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