TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DESLORATADINE

DESLORATADINE
Approved 2010-02-19
Jump to: Indications Approvals Trials Competitors Safety Patents
11
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2010-02-19
Routes
ORAL
Dosage Forms
TABLET, TABLET, ORALLY DISINTEGRATING, SOLUTION

Companies

CHARTWELL RX Sun Pharma REDDYS TARO ZYDUS PHARMS USA AJENAT PHARMS DASH PHARMS ORBION PHARMS GLENMARK GENERICS Dr. Reddy's Lupin PERRIGO
Active Ingredient: DESLORATADINE

DESLORATADINE Approval History

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What DESLORATADINE Treats

11 FDA approvals

Originally approved for its first indication in 2010 . Covers 11 distinct patient populations.

  • Other (11)
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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.

DESLORATADINE FDA Label Details

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Data Sources

FDA Approval: ANDA078364 → Trials: ClinicalTrials.gov →

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