MedPath
FDA Product

Intralipid

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Intralipid

65219-531

Regulatory Information

65219-531

NDA018449

C73594

October 13, 2023

USA

These highlights do not include all the information needed to use INTRALIPID safely and effectively. See full prescribing information for INTRALIPID. INTRALIPID 20% (lipid injectable emulsion), for intravenous useInitial U.S. Approval: 1975

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

013547657

Active Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

EGG PHOSPHOLIPIDS

Code: 1Z74184RGV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

SOYBEAN OIL

Quantity: 20 g in 100 mL

Code: 241ATL177A

Class Code: ACTIB

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

SOYBEAN OIL

Code: 241ATL177A

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