FDA NDA · NDA019531

NUTRILIPID I.V. FAT EMULSION

soybean oil

Sponsor: B BRAUN

APPLICATION

NDA019531

TYPE

NDA

ORIGINAL APPROVAL

1993-05-28

LATEST ACTION

2025-07-24

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Discontinued, Prescription

Products

NUTRILIPID 10% · ReferenceDiscontinued

SOYBEAN OIL 10% · INJECTABLE · INJECTION

NUTRILIPID 20% · ReferencePrescription

SOYBEAN OIL 20% · INJECTABLE · INJECTION

2025-07-24Labeling · Supplement 18 · standard — Letter ↗AP

2025-07-24Labeling · Supplement 17 · standard — Letter ↗AP

2023-05-17Labeling · Supplement 16 · standard — Label ↗AP

2023-05-17Manufacturing (CMC) · Supplement 13 — Letter ↗AP

2020-07-14Labeling · Supplement 10 · standard — Label ↗AP

2015-12-02Manufacturing (CMC) · Supplement 3 · standardAP

2014-08-12Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP

1993-05-28Type 5 - New Formulation or New Manufacturer · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.