Data updated: Sep 20, 2026
FEXOFENADINE HYDROCHLORIDE · Dr. Reddy's
Immunology
Approved 1996-07-25
10
Indications
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1996-07-25
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION, CAPSULE
Companies
Dr. Reddy's Teva RANBAXY LABS LTD Aurobindo Pharma CONTRACT PHARMACAL RISING P AND L Novartis L PERRIGO CO
Active Ingredient: FEXOFENADINE HYDROCHLORIDE
Website: ↗
FEXOFENADINE HYDROCHLORIDE Approval History
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
76 FDA actions from 2005 to 2026
Aug 2026 SUPPL
Mfg · Manufacturing (CMC)
Jul 2026 ORIGINAL
Update
Feb 2025 ORIGINAL
Update
May 2023 ORIGINAL
Update
Nov 2022 SUPPL
Mfg
Jul 2022 SUPPL
Mfg
Mar 2020 SUPPL
Label
Feb 2020 ORIGINAL
Update
Oct 2019 SUPPL
Label
May 2016 SUPPL
Mfg
Sep 2013 SUPPL
Mfg
Jan 2013 SUPPL
Mfg
Dec 2012 SUPPL
Label
Sep 2011 SUPPL
Mfg
Jul 2011 SUPPL
Mfg
Apr 2011 SUPPL
Mfg
Apr 2011 SUPPL
Mfg
May 2010 SUPPL
Mfg
Mar 2009 SUPPL
Label
Jan 2009 SUPPL
Label
Apr 2008 SUPPL
Label
Apr 2007 ORIGINAL
Update
Jan 2007 SUPPL
Label
Jul 2006 SUPPL
Label
Apr 2006 ORIGINAL
Update
Sep 2005 ORIGINAL
Update
Aug 2005 ORIGINAL
Update
Jul 2005 ORIGINAL
Update
What FEXOFENADINE HYDROCHLORIDE Treats
10 FDA approvalsOriginally approved for its first indication in 2005 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Jul 2005)
- • Approved indication (Aug 2005)
- • Approved indication (Sep 2005)
- • Approved indication (Apr 2006)
- • Approved indication (Apr 2007)
- • Approved indication (Jul 2012)Letter
- • Approved indication (Feb 2020)
- • Approved indication (May 2023)
- • Approved indication (Feb 2025)
- • Approved indication (Jul 2026) New
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
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.
FEXOFENADINE HYDROCHLORIDE FDA Label Details
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Full clinical data, patents, trials, and competitive landscape for fexofenadine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.