Orange Book product · Brand (NDA)

OMEGAVEN

FISH OIL TRIGLYCERIDES

Brand (NDA)NDA 210589RX FRESENIUS KABI USA

Jul 27, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 27, 2018
8 yr ago
Today
Patent 9566260 expires
Listed drug product patent expiration.
Jul 30, 2026
in 1 mo

Active ingredient

FISH OIL TRIGLYCERIDES

Strength

5GM/50ML (0.1GM/ML)

Dosage form

EMULSION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210589

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9566260	Jul 30, 2026	in 1 mo	ProductU-2366