TheraRadar
Data updated: Sep 20, 2026

ALLEGRA HIVES (fexofenadine hydrochloride) · CHATTEM SANOFI

Immunology Approved 2000-02-25
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
26
Years on Market

Details

Status
Discontinued
First Approved
2000-02-25
Routes
ORAL
Dosage Forms
TABLET

Companies

CHATTEM SANOFI
Active Ingredient: FEXOFENADINE HYDROCHLORIDE

ALLEGRA HIVES Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
52 FDA actions from 2000 to 2023 · 3 indication expansions
Aug 2023 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Oct 2021 SUPPL
Label · Labeling
FDA Letter Label
May 2016 SUPPL
Label · Labeling
FDA Letter Label

What ALLEGRA HIVES Treats

4 FDA approvals

Originally approved for its first indication in 2000 . Covers 4 distinct patient populations.

  • Other (4)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT06548204 FEND-AMI YAN2024-0866 Ph 2 recruiting Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial
NCT01888718 671/10 Ph 1 completed Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ALLEGRA HIVES FDA Label Details

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Data Sources

FDA Approval: NDA020872 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.