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 5 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLEGRA ALLERGYFEXOFENADINE HYDROCHLORIDEA-S Medication Solutionsb5ce28f8-f6c3-4113-9317-e1c98e5030ef2024-07-30WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
allergy reliefFEXOFENADINE HYDROCHLORIDEMeijer, Inc.deecbf76-be1d-4b27-85c6-17cfb7e7d1a12024-07-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.c547c163-2a19-10d8-e053-2a95a90ac8172024-07-24WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
basic care allergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc2f30390-3d32-4489-9df2-caf848ce040b2024-07-17WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDECVS PHARMACY, INC7bc13851-291a-4582-8261-13c5022fbdd12024-05-24WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEAMERISOURCE BERGEN2a578643-adc1-44ca-83f2-9d48527bd3a42024-05-14WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC27202f58-a488-42cc-b63f-be892c5b4de22024-05-10WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Basic Care AllergyFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLCc29d281f-89dd-4c69-8572-6599400c660f2024-04-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
allergy reliefFEXOFENADINE HYDROCHLORIDEWalgreen Companya0738300-7262-4e43-89a6-0d0a60bd14bd2024-02-14WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDESafeway, Inc.348b79cf-1184-46d4-a0e5-fdc24afec1a52024-02-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.1f8a2f98-7eba-48df-9589-58587d67ae0e2024-01-03WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dc0893-b81b-4f96-e053-6294a90a856f2023-11-02WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDETOPCO ASSOCIATES LLCc4f9224c-4c3d-74bd-e053-2995a90a14522023-10-30WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDE ORALAurohealth LLCe8e35d7a-a86b-4d37-979b-f454978f070b2023-06-06WarningsName fallback
brand name: Fexofenadine Hydrochloride
Allergy ReliefFEXOFENADINE HYDROCHLORIDEChain Drug Marketing Association, Inc.fabb8c0d-b4da-ab73-e053-6394a90ab8b52023-05-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
allergy reliefFEXOFENADINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIccff9b0f-8ae5-057f-e053-2a95a90ac2b12023-05-17WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
kirkland signature aller fexFEXOFENADINE HYDROCHLORIDECostco Wholesale Company651d14d1-c5de-4cb9-9484-b05986e641ac2023-05-02WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEStrategic Sourcing Services, LLCde438313-9790-b4ea-2d28-7a19836cf5e22023-04-21WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Crcle Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEInnovus Pharmaceuticals, Inc.f7784610-7ca5-4489-b391-f2b3f3f6549b2023-04-08WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESafrel Pharmaceuticals, LLC.d6120f56-ab28-2696-e053-2995a90adf472023-03-28WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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