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GADAVIST

NDA · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2011-03-14

Drug application

FDA Application #

NDA201277

Application type

New Drug Application

Brand name

GADAVIST

Generic name

GADOBUTROL

Active ingredients

GADOBUTROL

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

BAYER HLTHCARE

Manufacturer

Bayer HealthCare Pharmaceuticals Inc.

First approval

2011-03-14

Source

Authoritative

Drugs@FDA application overview

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