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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 017643


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NDA 017643 describes INTRALIPID 10%, which is a drug marketed by Fresenius and is included in one NDA. It is available from one supplier. Additional details are available on the INTRALIPID 10% profile page.

The generic ingredient in INTRALIPID 10% is soybean oil. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the soybean oil profile page.
Summary for 017643
Tradename:INTRALIPID 10%
Applicant:Fresenius
Ingredient:soybean oil
Patents:0
Pharmacology for NDA: 017643
Suppliers and Packaging for NDA: 017643
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTRALIPID 10% soybean oil INJECTABLE;INJECTION 017643 NDA Baxter Healthcare CORP 0338-0518 0338-0518-12 250 mL in 1 BAG (0338-0518-12)
INTRALIPID 10% soybean oil INJECTABLE;INJECTION 017643 NDA Baxter Healthcare CORP 0338-0518 0338-0518-13 500 mL in 1 BAG (0338-0518-13)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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