TheraRadar
Data updated: May 26, 2026

TYZINE (tetrahydrozoline hydrochloride)

Osmotic Activity
Ophthalmology Approved 1979-11-30

TYZINE is indicated for the treatment of Eye Irritation; Dry Eye.

Source: FDA Label • FOUGERA PHARMS
1
Indication
--
Phase 3 Trials
46
Years on Market

Details

Status
Prescription
First Approved
1979-11-30
Routes
NASAL
Dosage Forms
SOLUTION, SPRAY

Companies

Active Ingredient: TETRAHYDROZOLINE HYDROCHLORIDE

TYZINE Approval History

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Original
New Indication
New Form
Label Update
45 FDA actions from 1979 to 2000
Nov 2000 SUPPL
Mfg · Manufacturing (CMC)
Jul 1993 SUPPL
Mfg · Manufacturing (CMC)
Sep 1990 SUPPL
Mfg · Manufacturing (CMC)

What TYZINE Treats

2 indications

TYZINE is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Eye Irritation
  • Dry Eye
Source: FDA Label

TYZINE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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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

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.

TYZINE FDA Label Details

Indications & Usage

TYZINE is indicated for the treatment of Eye Irritation; Dry Eye.

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Data Sources

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