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FDA Approval

Smoflipid

CompanyFresenius Kabi USA, LLC (DUNS: 608775388)

Effective Date

July 14, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Soybean oil(6 g in 100 mL)

Medium-chain triglycerides(6 g in 100 mL)

Olive oil(5 g in 100 mL)

Fish oil(3 g in 100 mL)

Manufacturing Establishments (1)

Fresenius Kabi AB Uppsala

Labeler

Fresenius Kabi USA, LLC

DUNS Number

559785113

Products (1)

Smoflipid

NDC Product Code

63323-820

Application Number

NDA207648

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

August 30, 2019

Ingredients

.ALPHA.-TOCOPHEROL, DL-Inactive

Code: 7QWA1RIO01Class: IACT

SODIUM OLEATEInactive

Code: 399SL044HNClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

EGG PHOSPHOLIPIDSInactive

Code: 1Z74184RGVClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Soybean oilActive

Code: 241ATL177AClass: ACTIBQuantity: 6 g in 100 mL

Medium-chain triglyceridesActive

Code: C9H2L21V7UClass: ACTIBQuantity: 6 g in 100 mL

Olive oilActive

Code: 6UYK2W1W1EClass: ACTIBQuantity: 5 g in 100 mL

Fish oilActive

Code: XGF7L72M0FClass: ACTIBQuantity: 3 g in 100 mL

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Dosage and Administration (2.1, 2.3)	5/2023
Warnings and Precautions (5.1)	5/2023

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