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DATSCAN

NDA · New Drug Application · Sponsor: GE HLTHCARE INC · Approved 2011-01-14

Drug application

FDA Application #

NDA022454

Application type

New Drug Application

Brand name

DATSCAN

Generic name

IOFLUPANE I-123

Active ingredients

IOFLUPANE I-123

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

GE HLTHCARE INC

Manufacturer

Medi-Physics Inc. dba GE Healthcare.

First approval

2011-01-14

Source

Authoritative

Drugs@FDA application overview

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