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Data updated: Mar 10, 2026

ZONALON

DOXEPIN HYDROCHLORIDE
Immunology Approved 1994-04-01
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1994-04-01
Routes
TOPICAL
Dosage Forms
CREAM

Companies

Viatris
Active Ingredient: DOXEPIN HYDROCHLORIDE

ZONALON Approval History

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What ZONALON Treats

3 indications

ZONALON is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pruritus
  • Atopic Dermatitis
  • Lichen Simplex Chronicus
Source: FDA Label

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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.

ZONALON FDA Label Details

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Indications & Usage

FDA Label (PDF)

Zonalon ® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION .)

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Data Sources

FDA Approval: NDA020126 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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