← FDA DRUG APPROVALS

FDA NDA · NDA020248

INTRALIPID

i.v. fat emulsion

Sponsor: FRESENIUS

APPLICATION
NDA020248
TYPE
NDA
ORIGINAL APPROVAL
1996-08-07
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INTRALIPID 20% · ReferencePrescription
SOYBEAN OIL 20% · INJECTABLE · INJECTION

Approval history

2025-07-24Labeling · Supplement 31 · standard — Label ↗AP
2023-05-17Labeling · Supplement 28 · standard — Label ↗AP
2023-05-17Labeling · Supplement 27 · standard — Label ↗AP
2022-05-03Labeling · Supplement 26 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 22 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 20 · standard — Label ↗AP
2010-05-03Labeling · Supplement 16AP
2005-05-13Labeling · Supplement 13AP
2001-08-23Manufacturing (CMC) · Supplement 6 · standardAP
2001-08-23Manufacturing (CMC) · Supplement 7 · standardAP
2001-08-23Manufacturing (CMC) · Supplement 5 · standardAP
2000-10-10Manufacturing (CMC) · Supplement 4 · standardAP
2000-08-01Manufacturing (CMC) · Supplement 3 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 1 · standardAP
1996-08-07Type 3 - New Dosage Form · Original · standardAP
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