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GADOBUTROL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: VIWIT PHARM · Approved 2026-06-11

Drug application

FDA Application #

ANDA219287

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

VIWIT PHARM

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2026-06-11

Source

Authoritative

Drugs@FDA application overview

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