Data updated: Nov 8, 2026
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (fexofenadine hydrochloride) · Dr. Reddy's
Immunology
Approved 2005-09-01
10
Indications
--
Phase 3 Trials
21
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2005-09-01
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, TABLET, SUSPENSION
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 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
30 FDA actions from 2005 to 2020
Mar 2020 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label · Labeling
Nov 2017 ORIGINAL
Update
Sep 2017 SUPPL
Mfg
Aug 2016 ORIGINAL
Update
Feb 2015 SUPPL
Mfg
Nov 2014 ORIGINAL
Update
Nov 2014 ORIGINAL
Update
Nov 2014 SUPPL
Mfg
Sep 2013 SUPPL
Mfg
Jan 2013 SUPPL
Mfg
Dec 2012 SUPPL
Label
Feb 2012 ORIGINAL
Update
Feb 2012 ORIGINAL
Update
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
What CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY Treats
10 FDA approvalsOriginally approved for its first indication in 2005 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Sep 2005)
- • Approved indication (Apr 2006)
- • Approved indication (Apr 2007)
- • Approved indication (Feb 2012)
- • Approved indication (Feb 2012)
- • Approved indication (Jan 2013)Label Letter
- • Approved indication (Nov 2014)
- • Approved indication (Nov 2014)
- • Approved indication (Aug 2016)
- • Approved indication (Nov 2017)
📋
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.
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.