Overview
Antibacterial agent used primarily as a tuberculostatic. It remains the treatment of choice for tuberculosis.
Indication
Isoniazid is used for the treatment of all forms of tuberculosis in which organisms are susceptible. It is also used in combination with rifampin and pyrazinamide.
Associated Conditions
- Active Tuberculosis
- Mycobacterium kansasii infection
- Late phase Tuberculosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
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 | ||
2025/03/13 | Phase 4 | Active, not recruiting | |||
2024/07/22 | Not Applicable | Completed | |||
2024/02/12 | Phase 3 | Recruiting | |||
2024/01/05 | Phase 3 | Not yet recruiting | |||
2024/01/05 | Phase 2 | Suspended | |||
2023/11/02 | Phase 2 | Recruiting | |||
2023/09/01 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Blenheim Pharmacal, Inc. | 10544-218 | ORAL | 300 mg in 1 1 | 4/20/2010 | |
Physicians Total Care, Inc. | 54868-2416 | ORAL | 300 mg in 1 1 | 3/4/2013 | |
Department of State Health Services, Pharmacy Branch | 55695-033 | ORAL | 300 mg in 1 1 | 3/11/2016 | |
Rebel Distributors Corp | 21695-627 | ORAL | 300 mg in 1 1 | 1/20/2010 | |
Contract Pharmacy Services-PA | 67046-333 | ORAL | 300 mg in 1 1 | 10/20/2006 | |
Sandoz Inc | 0781-3056 | INTRAMUSCULAR | 100 mg in 1 mL | 10/11/2022 | |
VersaPharm Incorporated | 61748-016 | ORAL | 100 mg in 1 1 | 8/12/2010 | |
Liberty Pharmaceuticals, Inc. | 0440-1655 | ORAL | 300 mg in 1 1 | 4/3/2014 | |
H.J. Harkins Company, Inc. | 52959-145 | ORAL | 300 mg in 1 1 | 1/20/2010 | |
Aphena Pharma Solutions - Tennessee, LLC | 71610-395 | ORAL | 300 mg in 1 1 | 3/23/2020 |
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 |
---|---|---|---|---|---|
PDP-ISONIAZID TABLET 300 mg | SIN06651P | TABLET | 300 mg | 10/29/1991 | |
ISONIAZID TABLET 100 mg | ATLANTIC LABORATORIES CORPN LTD | SIN01302P | TABLET | 100 mg | 5/19/1988 |
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 |
---|---|---|---|---|---|
PHARMASERVE INAH TAB 100MG | N/A | N/A | N/A | 2/16/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NOUMED ISONIAZID 100mg tablet bottle | 483125 | Medicine | A | 3/19/2025 | |
ISONIAZID 100mg tablet bottle | 13455 | Medicine | A | 8/30/1991 | |
Rifinah 300/150mg | 345792 | Medicine | A | 10/12/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
PMS-ISONIAZID | 02514907 | Tablet - Oral | 100 MG | N/A | |
PDP-ISONIAZID | pendopharm division of pharmascience inc | 00577790 | Tablet - Oral | 100 MG | 12/31/1984 |
ISONIAZID TAB 300MG | sands pharm | 00310247 | Tablet - Oral | 300 MG / TAB | 12/31/1974 |
ISONIAZID SYRUP 50MG/5ML | carolina medical products company | 00722464 | Syrup - Oral | 50 MG / 5 ML | 12/31/1987 |
ISOTAMINE | bausch health, canada inc. | 00261289 | Powder - Oral | 500 G / BOTTLE | 12/31/1976 |
PMS-ISONIAZID | 02514893 | Tablet - Oral | 50 MG | N/A | |
PMS-ISONIAZID | 02514923 | Solution - Oral | 50 MG / 5 ML | N/A | |
ISOTAMINE | bausch health, canada inc. | 00261270 | Tablet - Oral | 100 MG | 12/31/1972 |
ISOTAMINE B 300 | bausch health, canada inc. | 00236799 | Tablet - Oral | 300 MG | 12/31/1967 |
ISONIAZIDE 100MG TABLETS | 02232756 | Tablet - Oral | 100 MG / TAB | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CEMIDON B6 300 MG/50 MG COMPRIMIDOS | Chiesi España S.A.U. | 63335 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
RIFINAH 300 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA | Sanofi Aventis S.A. | 54213 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
CEMIDON B6 150 MG/25 MG COMPRIMIDOS | Chiesi España S.A.U. | 40689 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
CEMIDON B6 50 MG/15 MG COMPRIMIDOS | Chiesi España S.A.U. | 38394 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
RIMSTAR COMPRIMIDOS RECUBIERTOS CON PELICULA | 65904 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
CEMIDON 60 MG/ML SOLUCIÓN INYECTABLE | Chiesi España S.A.U. | 18697 | SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
RIFATER COMPRIMIDOS RECUBIERTOS | Sanofi Aventis S.A. | 58299 | 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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