Overview
Ethambutol is a bacteriostatic agent indicated alongside medications such as isoniazid, rifampin, and pyrazinamide in the treatment of pulmonary tuberculosis. Ethambutol was first described in the literature in 1961. It was developed out of a need for therapies active against isoniazid resistant strains of Mycobacterium tuberculosis. Ethambutol was granted FDA approval on 6 November 1967.
Indication
Ethambutol is indicated in combination with other anti-tuberculosis drugs in the treatment of pulmonary tuberculosis. Ethambutol is commonly used in combination with isoniazid, rifampin, and pyrazinamide.
Associated Conditions
- Mycobacterium Avium Intracellulare Complex (MAC)
- Mycobacterium Infections
- Pulmonary Tuberculosis (TB)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/24 | Not Applicable | Not yet recruiting | Bin Cao | ||
2025/07/22 | Not Applicable | Not yet recruiting | Shenzhen Third People's Hospital | ||
2025/04/08 | Phase 2 | Not yet recruiting | Shandong University | ||
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2024/02/12 | Phase 3 | Recruiting | |||
2024/01/05 | Phase 2 | Suspended | |||
2023/11/02 | Phase 2 | Recruiting | |||
2023/10/13 | Phase 3 | Active, not recruiting | Beijing Chest Hospital | ||
2023/08/01 | Phase 1 | Completed | |||
2023/03/13 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 68084-280 | ORAL | 400 mg in 1 1 | 7/7/2022 | |
| A-S Medication Solutions | 50090-2337 | ORAL | 100 mg in 1 1 | 5/16/2019 | |
| STI Pharma | 68850-005 | ORAL | 400 mg in 1 1 | 1/31/2011 | |
| Department of State Health Services, Pharmacy Branch | 55695-035 | ORAL | 400 mg in 1 1 | 2/11/2016 | |
| REMEDYREPACK INC. | 70518-3662 | ORAL | 100 mg in 1 1 | 3/27/2024 | |
| Epic Pharma, LLC | 42806-102 | ORAL | 400 mg in 1 1 | 7/30/2020 | |
| STI Pharma, LLC | 68850-012 | ORAL | 400 mg in 1 1 | 2/15/2022 | |
| STI Pharma | 68850-004 | ORAL | 100 mg in 1 1 | 1/31/2011 | |
| Lupin Pharmaceuticals, Inc. | 68180-280 | ORAL | 100 mg in 1 1 | 1/20/2024 | |
| A-S Medication Solutions | 50090-3948 | ORAL | 400 mg in 1 1 | 10/26/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| EBUTOL-100 TABLET 100 mg | SIN03004P | TABLET, FILM COATED | 100 mg | 6/5/1989 | |
| EBUTOL-400 TABLET 400 mg | SIN03005P | TABLET, FILM COATED | 400 mg | 6/5/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ETHAMBUTOL LUPIN ethambutol hydrochloride 400 mg tablet bottle | 365231 | Medicine | A | 7/13/2022 | |
| MYAMBUTOL tablets 100mg | 47887 | Medicine | A | 2/16/1994 | |
| ETHAMBUTOL GH ethambutol hydrochloride 400 mg tablet blister pack | 365233 | Medicine | A | 7/13/2022 | |
| ETHAMBUTOL GH ethambutol hydrochloride 400 mg tablet bottle | 365236 | Medicine | A | 7/13/2022 | |
| ETHAMBUTOL LUPIN ethambutol hydrochloride 400 mg tablet blister pack | 365232 | Medicine | A | 7/13/2022 | |
| MYAMBUTOL ethambutol hydrochloride 400mg tablet | 147246 | Medicine | A | 2/20/2008 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MYAMBUTOL TABLETS - 400 MG | wyeth-ayerst canada inc. | 02170078 | Tablet - Oral | 400 MG | 11/15/1996 |
| MYAMBUTOL TAB 100MG | lederle cyanamid canada inc. | 00127957 | Tablet - Oral | 100 MG / TAB | 12/31/1969 |
| ETIBI | bausch health, canada inc. | 00247979 | Tablet - Oral | 400 MG | 12/31/1972 |
| MYAMBUTOL TAB 400MG | lederle cyanamid canada inc. | 00127965 | Tablet - Oral | 400 MG / TAB | 12/31/1969 |
| ETIBI | bausch health, canada inc. | 00247960 | Tablet - Oral | 100 MG | 12/31/1972 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| Myambutol 400 mg comprimidos recubiertos | Teofarma S.R.L. | 44430 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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