APPLICATION
ANDA204146
TYPE
ANDA
ORIGINAL APPROVAL
2024-04-01
LATEST ACTION
2024-04-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IBUTILIDE FUMARATEPrescription
IBUTILIDE FUMARATE 0.1MG/ML · INJECTABLE · INJECTION
Approval history
2024-04-01UNKNOWN · OriginalAP
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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