APPLICATION
ANDA216081
TYPE
ANDA
ORIGINAL APPROVAL
2023-09-08
LATEST ACTION
2026-05-01
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
GADOBUTROLDiscontinued
GADOBUTROL 6.0472GM/10ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLDiscontinued
GADOBUTROL 1.20944GM/2ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 18.1416GM/30ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLDiscontinued
GADOBUTROL 9.0708GM/15ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLDiscontinued
GADOBUTROL 4.5354GM/7.5ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
GADOBUTROLPrescription
GADOBUTROL 39.3068GM/65ML (604.72MG/ML) · SOLUTION · INTRAVENOUS
Approval history
2026-05-01Labeling · Supplement 9 · standardAP
2026-05-01Labeling · Supplement 7 · standardAP
2024-08-19Labeling · Supplement 4 · standardAP
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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