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

Summary for NDA: 018449

Tradename:
INTRALIPID 20%
Applicant:
Fresenius
Ingredient:
soybean oil
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018449

Ingredient-typeLipids

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 CORP 0338-0519 0338-0519-14 1000 mL in 1 BAG (0338-0519-14)
INTRALIPID 20%
soybean oil
INJECTABLE;INJECTION 018449 NDA Baxter Healthcare CORP 0338-0519 0338-0519-04 1000 mL in 1 BAG (0338-0519-04)

Summary 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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