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Last Updated: June 22, 2021

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Details for New Drug Application (NDA): 018449

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NDA 018449 describes INTRALIPID 20%, which is a drug marketed by Fresenius and is included in two NDAs. It is available from two suppliers. Additional details are available on the INTRALIPID 20% profile page.

The generic ingredient in INTRALIPID 20% is soybean oil. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the soybean oil profile page.
Summary for 018449
Tradename:INTRALIPID 20%
Ingredient:soybean oil
Formulation / Manufacturing:see details
Pharmacology for NDA: 018449
Suppliers and Packaging for NDA: 018449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTRALIPID 20% soybean oil INJECTABLE;INJECTION 018449 NDA Baxter Healthcare Corporation 0338-0519 0338-0519-09 250 mL in 1 BAG (0338-0519-09)
INTRALIPID 20% soybean oil INJECTABLE;INJECTION 018449 NDA Baxter Healthcare Corporation 0338-0519 0338-0519-13 500 mL in 1 BAG (0338-0519-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

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