APPLICATION
ANDA215508
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-06
LATEST ACTION
2024-05-06
ROUTE
SOLUTION, INTRAVENOUS
DOSAGE FORM
INJECTION, SOLUTION
MARKETING STATUS
None (Tentative Approval), Prescription
Products
EDARAVONENone (Tentative Approval)
EDARAVONE 60mg/100mL · INJECTION · SOLUTION
EDARAVONEPrescription
EDARAVONE 30MG/100ML (0.3MG/ML) · SOLUTION · INTRAVENOUS
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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