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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. Three suppliers are listed for this compound. Additional details are available on the soybean oil profile page.

Summary for NDA: 017643

Formulation / Manufacturing:see details

Pharmacology for NDA: 017643


Suppliers and Packaging for NDA: 017643

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
soybean oil
INJECTABLE;INJECTION 017643 NDA Baxter Healthcare CORP 0338-0518 0338-0518-12 250 mL in 1 BAG (0338-0518-12)
soybean oil
INJECTABLE;INJECTION 017643 NDA Baxter Healthcare CORP 0338-0518 0338-0518-13 500 mL in 1 BAG (0338-0518-13)

Summary for product number 001

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

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