← FDA DRUG APPROVALS

FDA NDA · NDA018449

INTRALIPID

i.v. fat emulsion

Sponsor: FRESENIUS

APPLICATION
NDA018449
TYPE
NDA
ORIGINAL APPROVAL
1981-01-23
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 54 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 50 · standard — Label ↗AP
2023-05-17Labeling · Supplement 51 · standard — Label ↗AP
2022-05-03Labeling · Supplement 49 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 45 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 43 · standard — Label ↗AP
2007-04-24Labeling · Supplement 39 · standard — Label ↗AP
2004-04-16Manufacturing (CMC) · Supplement 37 · standard — Letter ↗AP
2001-08-22Manufacturing (CMC) · Supplement 32 · standardAP
2000-12-28Labeling · Supplement 27 · standardAP
2000-09-27Manufacturing (CMC) · Supplement 31 · standardAP
1999-07-21Manufacturing (CMC) · Supplement 30 · standardAP
1999-03-18Manufacturing (CMC) · Supplement 29 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 28 · standardAP
1995-02-17Manufacturing (CMC) · Supplement 26 · standardAP
1994-05-18Manufacturing (CMC) · Supplement 21 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 22 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 24 · standardAP
1990-06-20Manufacturing (CMC) · Supplement 19 · standardAP
1990-06-20Labeling · Supplement 20AP
1989-04-10Manufacturing (CMC) · Supplement 18 · standardAP
1988-09-19Labeling · Supplement 13AP
1985-04-10Manufacturing (CMC) · Supplement 17 · standardAP
1985-01-31Manufacturing (CMC) · Supplement 16 · standardAP
1984-07-27Manufacturing (CMC) · Supplement 15 · standardAP
1984-05-02Manufacturing (CMC) · Supplement 14 · standardAP
1984-02-15Manufacturing (CMC) · Supplement 1 · standardAP
1983-06-07Labeling · Supplement 8AP
1983-05-27Manufacturing (CMC) · Supplement 11 · standardAP
1983-05-27Labeling · Supplement 10AP
1982-07-06Manufacturing (CMC) · Supplement 9 · standardAP
1982-07-06Labeling · Supplement 3AP
1982-02-02Manufacturing (CMC) · Supplement 7 · standardAP
1981-07-01Manufacturing (CMC) · Supplement 6 · standardAP
1981-04-03Manufacturing (CMC) · Supplement 4 · standardAP
1981-04-03Labeling · Supplement 2AP
1981-01-23Type 3 - New Dosage Form · Original · standardAP
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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