TheraRadar
Data updated: May 26, 2026

ETHAMBUTOL HYDROCHLORIDE

Infectious Disease Approved 1999-11-30

ETHAMBUTOL HYDROCHLORIDE is indicated for the treatment of Pulmonary Tuberculosis.

Source: FDA Label • Lupin
3
Indications
--
Phase 3 Trials
26
Years on Market

Details

Status
Prescription
First Approved
1999-11-30
Routes
ORAL
Dosage Forms
TABLET

ETHAMBUTOL HYDROCHLORIDE Approval History

2000
2001
2002
2003
2004
2005
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
15 FDA actions from 1999 to 2012
Jan 2012 SUPPL
Label · Labeling
Jan 2012 SUPPL
Label · Labeling
Jun 2009 ORIGINAL
Update

What ETHAMBUTOL HYDROCHLORIDE Treats

1 indications

ETHAMBUTOL HYDROCHLORIDE is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pulmonary Tuberculosis
Source: FDA Label

ETHAMBUTOL 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.

Drugs Similar to ETHAMBUTOL HYDROCHLORIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

PRIFTIN
RIFAPENTINE
1 shared
Sanofi
Shared indications:
Pulmonary Tuberculosis
SIRTURO
BEDAQUILINE FUMARATE
1 shared
Johnson & Johnson
Shared indications:
Pulmonary Tuberculosis
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Active Pipeline

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Key Completed Trials

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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.

ETHAMBUTOL HYDROCHLORIDE FDA Label Details

Indications & Usage

ETHAMBUTOL HYDROCHLORIDE is indicated for the treatment of Pulmonary Tuberculosis.

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Data Sources

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