← FDA Drug Approvals (Drugs@FDA)

GADOBUTROL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HENGRUI PHARMA · Approved 2023-09-08

Drug application

FDA Application #

ANDA216081

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

HENGRUI PHARMA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2023-09-08

Source

Authoritative

Drugs@FDA application overview

Machine

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