TheraRadar
Data updated: May 26, 2026

TETRACAINE HYDROCHLORIDE

Ophthalmology Approved 2016-02-29

Tetracaine Hydrochloride is a topical anesthetic used for medical procedures that require quick, short-term numbing of the eye. It helps patients undergoing ophthalmic interventions where a rapid onset of action is necessary. This solution provides a brief period of local anesthesia to facilitate various eye-related tasks.

Source: FDA Label • BAUSCH LOMB IRELAND

How TETRACAINE HYDROCHLORIDE Works

This medication works by blocking the sodium ion channels that are necessary for starting and carrying nerve impulses. By preventing these neuronal signals from traveling, the drug effectively produces a localized numbing effect in the eye.

3
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-02-29
Routes
OPHTHALMIC
Dosage Forms
SOLUTION

TETRACAINE HYDROCHLORIDE Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2016 to 2024
Dec 2024 ORIGINAL
Update
Feb 2022 SUPPL
Label · Labeling
Feb 2022 SUPPL
Label · Labeling

What TETRACAINE HYDROCHLORIDE Treats

1 indications

TETRACAINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Eye procedures requiring rapid, short-acting topical anesthesia
Source: FDA Label

TETRACAINE HYDROCHLORIDE 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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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.

TETRACAINE HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

TETRACAINE HYDROCHLORIDE is indicated for the treatment of Eye procedures requiring rapid, short-acting topical anesthesia.

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Data Sources

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