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OMEGAVEN

NDA · New Drug Application · Sponsor: FRESENIUS KABI USA · Approved 2018-07-27

Drug application

FDA Application #

NDA210589

Application type

New Drug Application

Brand name

OMEGAVEN

Generic name

FISH OIL

Active ingredients

FISH OIL TRIGLYCERIDES

Dosage form

EMULSION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

FRESENIUS KABI USA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2018-07-27

Source

Authoritative

Drugs@FDA application overview

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