FDA.reportPublic FDA data

Application 021963

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLEGRAFEXOFENADINE HYDROCHLORIDESUSPENSION;ORAL30MG/5MLYesNo

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
N021963-001ALLEGRAFEXOFENADINE HYDROCHLORIDE30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2006-10-16

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 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021963-001ALLEGRA30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2006-10-16c2088c7a36db…
2026-09-14 22:38:342026-08N021963-001ALLEGRA30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2006-10-1684e616aacf4f…
2026-08-18 06:07:402026-07N021963-001ALLEGRA30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2006-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021963-001ALLEGRA30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD2006-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-163f01610625f2…
2019-09-15 20:21 UTC2019-09N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021963-001ALLEGRA30MG/5MLSUSPENSION / ORALRLD2006-10-163a93d1ddd44b…

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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALLERGYFEXOFENADINE HYDROCHLORIDEAmazon.com Services LLC1b5aa481-205d-4935-ae58-fcb8cbc35c4c2026-09-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.b21bb11d-bf74-4ee7-9cfe-5b599a3c47752026-08-11WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC5413d84e-f945-4920-8981-f62978f21d672026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC683cb2ea-c913-48f4-8adc-2888da3b655e2026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLCeb8e67dc-e2df-4c35-bfd7-12af67e1354a2026-08-06WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072026-08-05WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-08-03WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
HIVES RELIEFFEXOFENADINE HYDROCHLORIDEWalgreen Companya79edb5d-02d9-4c53-9509-c69fd61156862026-07-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEKroger Company2718d6a2-0678-4703-9a5a-26b27d7539422026-07-20WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
equate allergy reliefFEXOFENADINE HYDROCHLORIDEWalmart Inc.852c8ad2-fc7d-4728-b2c6-f64b960fe2ab2026-07-18WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEBluePoint Laboratoriesa86aebd0-937e-5d73-e053-2995a90a656a2026-07-13WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Limited864e3052-5787-bf11-9d17-11274ca2304f2026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b0121213-eae1-8429-9986-3b3b26f35e472026-07-09WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDECVS PHARMACYc77ee2bb-dc95-d8c9-e053-2995a90a96022026-07-08WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Childrens AllergyFEXOFENADINE HYDROCHLORIDEH2-Pharma, LLC84988f6d-85b1-45dd-89be-0333acc6b1802026-06-25WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs58193632-2468-4159-b1a9-c24a489f199f2026-06-24WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Gencare-Allergy ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCa8595b29-1ea3-44aa-b131-030f34f408fc2026-06-22WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Ltd3151bc6d-b40b-4200-a5cf-e57b6791d92a2026-06-15WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEGranules India Limitede0537b71-fdee-4122-9c09-868ce73520802026-06-15WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEYYBA Corp53fe8ef5-ab65-f23e-e063-6394a90a30f02026-06-11WarningsName fallback
generic name: FEXOFENADINE 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
58961SUPPL2019-06-04
58906SUPPL2019-05-31
37960SUPPL2008-06-30
6547SUPPL2008-06-30
42361ORIG2008-03-14
28929ORIG2006-10-23
37959ORIG2006-10-18