← FDA DRUG APPROVALS

FDA NDA · NDA019942

INTRALIPID

i. v. fat emulsion

Sponsor: FRESENIUS

APPLICATION
NDA019942
TYPE
NDA
ORIGINAL APPROVAL
1993-12-30
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INTRALIPID 30% · ReferencePrescription
SOYBEAN OIL 30% · INJECTABLE · INJECTION

Approval history

2025-07-24Labeling · Supplement 25 · standard — Letter ↗AP
2024-02-22Labeling · Supplement 22 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 21 · standard — Label ↗AP
2022-05-03Labeling · Supplement 20 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 16 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 14 · standard — Letter ↗AP
2004-04-16Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2001-08-22Manufacturing (CMC) · Supplement 5 · standardAP
2000-09-27Manufacturing (CMC) · Supplement 4 · standardAP
1999-07-21Manufacturing (CMC) · Supplement 3 · standardAP
1999-03-18Manufacturing (CMC) · Supplement 2 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 1 · standardAP
1993-12-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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