FDA.reportPublic FDA data

Application 020625

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLEGRAFEXOFENADINE HYDROCHLORIDECAPSULE;ORAL60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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
N020625-001ALLEGRAFEXOFENADINE HYDROCHLORIDE60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25

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2026-10-15 13:18:302026-09N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25c2088c7a36db…
2026-09-14 22:38:342026-08N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-2584e616aacf4f…
2026-08-18 06:07:402026-07N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020625-001ALLEGRA60MGCAPSULE / ORAL1996-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020625-001ALLEGRA60MGCAPSULE / ORAL1996-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORAL1996-07-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020625-001ALLEGRA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL1996-07-253a93d1ddd44b…

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 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLCae0f16f6-d07a-47e1-adb8-07803c6cfb132024-12-13WarningsName fallback
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
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEKROGER COMPANY7b146260-c925-3238-d092-24b7101ceb502024-11-12WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine hydrochlorideFEXOFENADINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.624b3a91-af4f-8848-6fc3-392e0df34cc82024-11-12WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDECVS Health Corp.204506d7-7688-fd7e-0aae-142b698848ef2024-11-12WarningsName fallback
generic name: FEXOFENADINE HYDROCHLORIDE
Allergy ReliefFEXOFENADINE HYDROCHLORIDEHARRIS TEETERc4f9e849-f286-4167-e053-2a95a90a38f92024-10-11WarningsName 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
generic name: FEXOFENADINE HYDROCHLORIDE
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
generic name: FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDEAMERISOURCE BERGEN2a578643-adc1-44ca-83f2-9d48527bd3a42024-05-14WarningsName 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
57677ORIG2019-02-15
41490SUPPL2008-08-08
41489SUPPL2008-08-08
41491SUPPL2008-08-04
20770SUPPL2008-08-04
25341SUPPL2003-06-08
25340SUPPL2003-06-08
34974SUPPL2003-05-29
12863SUPPL2003-05-29
12862ORIG2003-04-30
2901SUPPL2001-07-11
51863SUPPL1900-01-01
51862SUPPL1900-01-01
51861SUPPL1900-01-01
51860SUPPL1900-01-01
51859SUPPL1900-01-01