Overview
An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.
Indication
For the treatment of petit mal epilepsy.
Associated Conditions
- Petit Mal Epilepsy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/06/16 | Phase 2 | Recruiting | University Hospital, Clermont-Ferrand | ||
2020/01/03 | Phase 3 | Recruiting | |||
2019/03/25 | Early Phase 1 | Completed | Zhejiang University | ||
2017/06/22 | N/A | Recruiting | |||
2016/11/25 | Phase 2 | UNKNOWN | University Hospital, Clermont-Ferrand | ||
2014/03/31 | Phase 2 | Completed | University Hospital, Clermont-Ferrand | ||
2011/01/17 | Phase 2 | Completed | |||
2010/05/13 | Phase 1 | Terminated | |||
2008/06/03 | Phase 2 | Terminated | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||
2004/07/27 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Akorn | 61748-025 | ORAL | 250 mg in 1 1 | 3/8/2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-532 | ORAL | 250 mg in 1 1 | 3/16/2020 | |
| Parke-Davis Div of Pfizer Inc | 0071-2418 | ORAL | 250 mg in 5 mL | 6/9/2023 | |
| Epic Pharma, LLC | 42806-711 | ORAL | 250 mg in 1 1 | 4/15/2020 | |
| Epic Pharma, LLC | 42806-708 | ORAL | 250 mg in 1 1 | 11/17/2021 | |
| Strides Pharma Science Limited | 64380-878 | ORAL | 250 mg in 1 1 | 11/22/2022 | |
| Parke-Davis Div of Pfizer Inc | 0071-0237 | ORAL | 250 mg in 1 1 | 6/8/2023 | |
| Banner Life Sciences LLC. | 69387-108 | ORAL | 250 mg in 1 1 | 5/15/2015 | |
| Bryant Ranch Prepack | 63629-8005 | ORAL | 250 mg in 1 1 | 1/18/2022 | |
| Bionpharma Inc. | 69452-152 | ORAL | 250 mg in 1 1 | 12/27/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| ETHOSUXIMIDE CAPSULES 250MG | N/A | w corporation limited | N/A | N/A | 12/9/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZARONTIN ethosuximide 250mg capsule bottle | 94175 | Medicine | A | 4/29/2003 | |
| ZARONTIN SYRUP ethosuximide 250mg/5mL oral liquid bottle | 79031 | Medicine | A | 6/27/2002 | |
| ZARONTIN ethosuximide 250mg capsule bottle | 461005 | Medicine | A | 1/2/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ZARONTIN | searchlight pharma inc | 00022799 | Capsule - Oral | 250 MG | 12/31/1960 |
| ODAN-ETHOSUXIMIDE | odan laboratories ltd | 02547171 | Capsule - Oral | 250 MG | 6/25/2024 |
| MAR-ETHOSUXIMIDE | marcan pharmaceuticals inc | 02545772 | Capsule - Oral | 250 MG | 6/19/2024 |
| ZARONTIN SYRUP | searchlight pharma inc | 00023485 | Syrup - Oral | 250 MG / 5 ML | 12/31/1964 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ZARONTIN 50mg/ml SOLUCION ORAL | Essential Pharma (M) Limited | 37828 | JARABE | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| ETOSUXIMIDA FAES 250 mg CAPSULAS DURAS | 42250 | CÁPSULA DURA | 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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