FDA.reportPublic FDA data

Application 076236

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGNoNo

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
A076236-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2005-04-14

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 UTC2022-10A076236-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2005-04-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076236-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2005-04-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076236-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2005-04-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076236-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2005-04-14a50c72e98297…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.4daddd32-615f-aedf-e063-6394a90a5b092026-09-01WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC4726af84-83c1-456d-995c-f6a8d1583f8b2026-05-27WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKroger Companyac67476a-2888-53c4-0a10-7f73ac2580c52025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporation0834bda9-e793-ad67-7f71-d2ffce47e5fc2025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreens Companydb671b6e-7233-8872-0227-6da62d6b65072025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWal-mart Stores, Inc.a0ce5002-08e3-c21f-9b88-f3dd27dc9dda2025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services, LLC23fdb518-8dcc-3671-f116-ea8c7b0a6e082025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Health Corpb009e6b1-57da-a002-1a9e-38a96cc041f12025-12-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAmeriSource Bergen4a8df3c9-bed3-4371-a1c1-59afe12203e22025-11-14WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.87ab4578-84de-475d-a4b0-eec969f172532025-11-13WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCbced0a2e-047e-456e-bbd2-495e83bf07ee2025-04-18WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8afc0167-17bf-4ccd-91c9-8fb9c4e241c12025-03-11WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC75236b23-af51-40b6-ad1b-f62a27093a162024-10-10WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.1fcb601c-19d2-4db9-938b-b4f98ba9332f2024-06-26WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy, Inc.e9161bb2-190f-14b3-e053-2995a90a9b2f2024-06-01WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEwalgreens1ed05c85-7a1c-440d-a5d7-e229528cedcd2024-05-28WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKROGER COMPANYb8b2c45d-3aba-d98a-e053-2a95a90a879b2024-05-18WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECardinal Healthc3b40d04-7eef-4c80-a604-808d2be72ad72024-05-06WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERugby Laboratoriescc6df813-9175-4c0b-a8e4-afcaa3aa833f2024-05-06WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy45d3ad69-a80a-4f91-9c9b-8b19a30144a32024-04-26WarningsName fallback
brand name: Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8880ORIG2005-04-19