Omegaven
These highlights do not include all the information needed to use OMEGAVEN safely and effectively. See full prescribing information for OMEGAVEN. OMEGAVEN (fish oil triglycerides) injectable emulsion, for intravenous useInitial U.S. Approval: 2018
Approved
Approval ID
5d9d0b24-e139-48bf-ab2d-536fb59cf8e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fish oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-205
Application NumberNDA210589
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fish oil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 19, 2023
FDA Product Classification
INGREDIENTS (7)
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Fish oilActive
Quantity: 0.1 g in 1 mL
Code: XGF7L72M0F
Classification: ACTIB
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
egg phospholipidsInactive
Code: 1Z74184RGV
Classification: IACT
sodium oleateInactive
Code: 399SL044HN
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT