← FDA Drug Approvals (Drugs@FDA)

GADOBUTROL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZENARA · Approved 2026-06-08

Drug application

FDA Application #

ANDA219146

Application type

Abbreviated New Drug Application (Generic)

Brand name

GADOBUTROL

Generic name

Gadobutrol

Active ingredients

GADOBUTROL

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

ZENARA

First approval

2026-06-08

Source

Authoritative

Drugs@FDA application overview

Machine

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