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Intralipid

Intralipid 20% A 20% I.V. Fat Emulsion In Excel Container

Approved
Approval ID

cbd3396e-6b85-41bf-82d2-940beba86686

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 9, 2019

Manufacturers
FDA

Baxter Healthcare Corporation

DUNS: 005083209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

I.V. Fat Emulsion

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0338-0519
Application NumberNDA020248
Product Classification
M
Marketing Category
C73594
G
Generic Name
I.V. Fat Emulsion
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 9, 2019
FDA Product Classification

INGREDIENTS (4)

SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Quantity: 1.2 g in 100 mL
Code: 1Z74184RGV
Classification: IACT
GLYCERINInactive
Quantity: 2.25 g in 100 mL
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILActive
Quantity: 20 g in 100 mL
Code: 241ATL177A
Classification: ACTIB

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Intralipid - FDA Drug Approval Details