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Details for New Drug Application (NDA): 019531

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NDA 019531 describes NUTRILIPID 20%, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the NUTRILIPID 20% profile page.

The generic ingredient in NUTRILIPID 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: 019531

Tradename:
NUTRILIPID 10%
Applicant:
B Braun
Ingredient:
soybean oil
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 019531

Ingredient-typeLipids

Suppliers and Packaging for NDA: 019531

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUTRILIPID 10%
soybean oil
INJECTABLE;INJECTION 019531 NDA B. Braun Medical Inc. 0264-4460 0264-4460-00 8 CARTON in 1 CASE (0264-4460-00) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER
NUTRILIPID 10%
soybean oil
INJECTABLE;INJECTION 019531 NDA B. Braun Medical Inc. 0264-4460 0264-4460-10 12 CARTON in 1 CASE (0264-4460-10) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10%
Approval Date:May 28, 1993TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20%
Approval Date:May 28, 1993TE:APRLD:Yes


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