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 4 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENUVICARE LLCec55732c-a3db-4445-a06d-0f98b21ed1342025-06-09WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCd3b6f04c-60d6-4ac3-9fb2-19eeb80f00a52025-06-01WarningsName fallback
brand name: FEXOFENADINE HYDROCHLORIDE
generic name: FEXOFENADINE HYDROCHLORIDE
exchange select aller easeFEXOFENADINE HYDROCHLORIDEArmy & Air Force Exchange Service6a9597a1-f024-4497-bc52-3d54827588222025-04-03WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Leader 24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECardinal Health 110, LLC. dba Leadere509800a-e33d-4d22-a6b4-97b7c73b14862025-04-01WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFSA STORE INC.276e9767-93c0-5932-e063-6394a90ab2d92025-03-07WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.f061d6b1-89f7-4d5f-ac59-9c73408517c12025-02-19WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.06115cea-5a44-409d-85ed-bb71743491c12025-02-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLC5307b7ef-0c22-4aae-a2f6-033d31032f552024-12-13WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLCae0f16f6-d07a-47e1-adb8-07803c6cfb132024-12-13WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEWalgreen Company99f03481-d169-4aac-8370-20011ff530ea2024-12-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDEWal-Mart Stores Inc2432f862-6d7e-666d-e063-6294a90acf742024-12-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDollar General1b2a14a1-a5cc-4f5e-8127-57e9d913f50a2024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEKROGER COMPANY7b146260-c925-3238-d092-24b7101ceb502024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.624b3a91-af4f-8848-6fc3-392e0df34cc82024-11-12WarningsName fallback
brand name: Fexofenadine hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Health Corp.204506d7-7688-fd7e-0aae-142b698848ef2024-11-12WarningsName fallback
brand name: Fexofenadine Hydrochloride
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHARRIS TEETERc4f9e849-f286-4167-e053-2a95a90a38f92024-10-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG CONSORTIUM8eee26c2-af58-469c-b855-c3bfc8bd7e2d2024-10-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCc5d58d74-da08-eb72-e053-2a95a90adc272024-10-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.5059ffc9-b116-4d11-9678-56c696f4e3db2024-08-16WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limited1d46555d-827b-b154-e063-6294a90ad3d52024-08-08WarningsName 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.