Composition
- Active ingredients
- EDARAVONE 30MG/100ML(0.3MG/ML)
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- EDARAVONE 60MG/100ML (0.6MG/ML) · SolutionANDA215917-001 · Discontinued
- EDARAVONE 60mg/100mL · InjectionANDA215508-002 · Tentative approval
- EDARAVONE 30MG/100ML (0.3MG/ML) · SolutionANDA215508-001 · Prescription
- EDARAVONE 30MG/100ML (0.3MG/ML) · SolutionANDA216902-001 · Prescription
- EDARAVONE 30MG/100ML (0.3MG/ML) · SolutionANDA216199-001 · Prescription
- EDARAVONE 60MG/100ML (0.6MG/ML) · SolutionANDA216199-002 · Discontinued
- EDARAVONE 30MG/100ML(0.3MG/ML) · InjectableThis page
- EDARAVONE 30MG/100ML (0.3MG/ML) · SolutionANDA217565-001 · Prescription
- EDARAVONE 60MG/100ML (0.6MG/ML) · SolutionANDA217565-002 · Prescription
- EDARAVONE 30MG/100ML (0.3MG/ML) · SolutionANDA218354-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218349.
At a glance
- Brand name
- Edaravone
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Zydus Pharms USA Inc
- Status
- Tentative approval
- FDA approval
- 13 Mar 2024
- Application
- ANDA218349-001