Treats pulmonary tuberculosis. Sold as Myambutol. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 15, 2026, FDA lists 4 applications for Ethambutol Hydrochloride (sold as Myambutol), first approved Nov 6, 1967, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Ethambutol HCl | Part D | $4.2M | +10% | 17,386 |
| Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry StudyNon-Puerperal Mastitis · Song Hongping | — | Recruiting | Oct 26, 2026 |
| Study of Combinations of Novel Promising Drugs for Pulmonary TuberculosisTuberculosis, Pulmonary · TASK Applied Science | Phase 2 | Not yet recruiting | Aug 19, 2026 |
| Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in KazakhstanTuberculosis, Tuberculosis Infection, Latent · Public Union "Kazakhstan Association of Phthisiopulmonologists" | — | Not yet recruiting | Jun 25, 2026 |
| Re-evaluating the Duration in Children of TB TreatmentTuberculosis · University of Wisconsin, Madison | Phase 2 | Not yet recruiting | Jun 18, 2026 |
| Short-Course Regimens for DS-PTB in AIDS PatientsTuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis · Shanghai Public Health Clinical Center | Not applicable | Not yet recruiting | May 27, 2026 |
| Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.Therapeutic Drug Monitoring (TDM), Tuberculosis · Beijing Chest Hospital | — | Enrolling by invitation | May 26, 2026 |
| A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)Tuberculosis · National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | Not yet recruiting | May 19, 2026 |
| Enhanced Treatment Strategy for Disseminated MAC Infection in HIV Patients: A Randomized Controlled TrialOpportunistic Infections, HIV Related, Disseminated Mycobacterium Avium Complex Infection · Shanghai Public Health Clinical Center | Not applicable | Not yet recruiting | May 13, 2026 |
| Nov 6, 1967 | MyambutolNDA 16320 · New molecular entity | Kanchan Hlthcare | 33 | Marketed |
| Nov 30, 1999 | Ethambutol HydrochlorideANDA 75095 | Epic Pharma LLC | 4 | Marketed |
| Nov 26, 2001 | Ethambutol HydrochlorideANDA 76057 | Barr | 2 | Discontinued |
| Jun 17, 2009 | Ethambutol HydrochlorideANDA 78939 | Lupin | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Lupin