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FDA NDA · NDA210589

OMEGAVEN

fish oil

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA210589
TYPE
NDA
ORIGINAL APPROVAL
2018-07-27
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

OMEGAVEN · ReferencePrescription
FISH OIL TRIGLYCERIDES 10GM/100ML (0.1GM/ML) · EMULSION · INTRAVENOUS
OMEGAVEN · ReferencePrescription
FISH OIL TRIGLYCERIDES 5GM/50ML (0.1GM/ML) · EMULSION · INTRAVENOUS

Approval history

2025-07-24Labeling · Supplement 5 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 3 · standard — Label ↗AP
2020-05-08Labeling · Supplement 1 · standard — Letter ↗AP
2018-07-27Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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