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DOTAREM

NDA · New Drug Application · Sponsor: GUERBET · Approved 2013-03-20

Drug application

FDA Application #

NDA204781

Application type

New Drug Application

Brand name

DOTAREM

Generic name

GADOTERATE MEGLUMINE

Active ingredients

GADOTERATE MEGLUMINE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

GUERBET

Manufacturer

Guerbet LLC

First approval

2013-03-20

Source

Authoritative

Drugs@FDA application overview

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