Soybean oil

Overview

Derived from soybeans, soybean oil is a common vegetable oil and a source of polyunsaturated and saturated fatty acids. It is a complex mixture of triglycerides where per 100 g, soybean oil has 16 g of saturated fat, 23 g of monounsaturated fat, and 58 g of polyunsaturated fat. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%). It is used as a cooking oil and lipid emulsion for parenteral nutrition in clinical settings. Soybean oil-based lipid emulsion is the only FDA-approved lipid formulation for clinical use.

Indication

Indicated for parenteral nutrition as a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Associated Conditions

Essential Fatty Acid Deficiency (EFAD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Intralipid	Fresenius Kabi USA, LLC	65219-539	INTRAVENOUS	20 g in 100 mL	10/13/2023
Intralipid	Fresenius Kabi USA, LLC	65219-533	INTRAVENOUS	20 g in 100 mL	10/13/2023
Intralipid	Baxter Healthcare Corporation	0338-0519	INTRAVENOUS	20 g in 100 mL	1/9/2019
Smoflipid	Fresenius Kabi USA, LLC	63323-820	INTRAVENOUS	6 g in 100 mL	8/15/2025
INTRALIPID	HF Acquisition Co LLC, DBA HealthFirst	51662-1333	INTRAVENOUS	20 g in 100 mL	2/22/2020
Kabiven	Fresenius Kabi USA, LLC	63323-712	INTRAVENOUS	3.9 g in 100 mL	8/2/2023
Clinolipid	Baxter Healthcare Corporation	0338-9540	INTRAVENOUS	4 g in 100 mL	7/24/2024
NutriLipid I.V. Fat Emulsion	B. Braun Medical Inc.	0264-4460	INTRAVENOUS	20 g in 100 mL	5/17/2023
Perikabiven	Fresenius Kabi USA, LLC	63323-714	INTRAVENOUS	3.5 g in 100 mL	8/7/2023
Intralipid	Baxter Healthcare Corporation	0338-0520	INTRAVENOUS	30 g in 100 mL	7/21/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
INTRALIPID INFUSION 20%	Fresenius Kabi SSPC, Fresenius Kabi AB	SIN05269P	INJECTION	200 mg/ml	12/15/1990
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16136P	INJECTION, EMULSION	8.7g/1000ml	3/24/2021
Lipidem 200mg/ml Emulsion for Infusion	B. Braun Melsungen AG	SIN13614P	EMULSION	80.00g/1000ml	3/16/2009
SMOFlipid 20%	Fresenius Kabi Austria GmbH, Fresenius Kabi AB	SIN13246P	INJECTION, EMULSION	60g per 1000ml	4/12/2007
LIPOFUNDIN MCT/LCT INFUSION 20%	B BRAUN MELSUNGEN AG	SIN05658P	INJECTION	100.0g/1000ml	4/8/1991
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16135P	INJECTION, EMULSION	8.7g/1000ml	3/24/2021
NUTRIFLEX® OMEGA PLUS EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15468P	INJECTION, EMULSION	16.00g/1000ml	4/23/2018
NUTRIFLEX® OMEGA SPECIAL B. BRAUN EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN16734P	INJECTION, EMULSION	16.00g/1000ml	3/7/2023
KABIVEN PERIPHERAL EMULSION FOR INFUSION	FRESENIUS KABI AB, FRESENIUS KABI AUSTRIA GMBH	SIN11718P	INJECTION	35.0 g/l	11/16/2001
NUTRIFLEX® OMEGA SPECIAL EMULSION FOR INFUSION	B. Braun Melsungen AG	SIN15469P	INJECTION, EMULSION	16.00g/1000ml	4/23/2018

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
OLIMEL N9E EMULSION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	10/24/2013
NUTRIFLEX OMEGA SPECIAL EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012
NUTRIFLEX OMEGA PLUS EMULSION FOR INFUSION	N/A	B BRAUN MEDICAL SA	N/A	N/A	1/11/2012

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL	180546	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
OLICLINOMEL N4-550 E 1000 mL IV emulsion for infusion with electrolytes bag	136599	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLICLINOMEL N4-550 E 2500 mL IV emulsion for infusion with electrolytes bag	141396	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLIMEL N5-860E Emulsion for intravenous infusion	197417	Baxter Healthcare Pty Ltd	Medicine	A	8/9/2013
Olimel N12-640 emulsion for intravenous infusion bag.	303755	Baxter Healthcare Pty Ltd	Medicine	A	7/1/2019
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag	329619	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020
INTRALIPID 20% 100mL injection bag	77745	Fresenius Kabi Australia Pty Ltd	Medicine	A	12/11/2001
SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 2463 mL	180550	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 986 mL	173891	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 1400 mL biofine bag	329617	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OLIMEL 5.7% E	baxter corporation	02352532	Emulsion - Intravenous	8 G / L	1/19/2011
OLIMEL 7.6% E	baxter corporation	02477955	Emulsion - Intravenous	7 G / L	10/25/2018
LIPOSYN III 20%	hospira healthcare ulc	02366819	Emulsion - Intravenous	200 MG / ML	N/A
LIPOSYN III 10%	hospira healthcare ulc	02366800	Emulsion - Intravenous	100 MG / ML	N/A
INTRALIPID 10%	fresenius kabi canada ltd	02065681	Emulsion - Intravenous	10 % / W/V	12/31/1995
PHYTOLECITHINE D	produits phyto inc.	00290912	Capsule - Oral	170 MG / CAP	12/31/1973
OLIMEL 5.7%	baxter corporation	02352540	Emulsion - Intravenous	8 G / L	3/1/2011
INTRALIPID 20%	fresenius kabi canada ltd	02065673	Emulsion - Intravenous	20 % / W/V	12/31/1995
OLIMEL 4.4%	baxter corporation	02352524	Emulsion - Intravenous	8 G / L	9/29/2011
LIPOSYN II INJ 10%	hospira healthcare ulc	00818712	Emulsion - Intravenous	5.0 G / 100 ML	1/1/1992

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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