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DEFITELIO

NDA · New Drug Application · Sponsor: JAZZ PHARMS INC · Approved 2016-03-30

Drug application

FDA Application #

NDA208114

Application type

New Drug Application

Brand name

DEFITELIO

Generic name

DEFIBROTIDE SODIUM

Active ingredients

DEFIBROTIDE SODIUM

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

JAZZ PHARMS INC

Manufacturer

Jazz Pharmaceuticals, Inc.

First approval

2016-03-30

Source

Authoritative

Drugs@FDA application overview

Machine

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