← FDA DRUG APPROVALS

FDA NDA · NDA017643

INTRALIPID

i.v. fat emulsion

Sponsor: FRESENIUS

APPLICATION
NDA017643
TYPE
NDA
ORIGINAL APPROVAL
1975-10-07
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

INTRALIPID 10% · ReferenceDiscontinued
SOYBEAN OIL 10% · INJECTABLE · INJECTION

Approval history

2025-07-24Labeling · Supplement 85 · standard — Label ↗AP
2023-05-17Labeling · Supplement 83 · standard — Label ↗AP
2022-05-03Labeling · Supplement 82 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 78 · standard — Letter ↗AP
2016-12-01Labeling · Supplement 76 · standard — Label ↗AP
2016-05-31Manufacturing (CMC) · Supplement 77 · standardAP
2016-04-21Manufacturing (CMC) · Supplement 75 · standardAP
2014-12-15Manufacturing (CMC) · Supplement 74 · standardAP
2007-04-24Labeling · Supplement 72 · standard — Letter ↗AP
2004-04-16Manufacturing (CMC) · Supplement 70 · standard — Letter ↗AP
2001-08-22Manufacturing (CMC) · Supplement 65 · standardAP
2000-12-20Labeling · Supplement 60 · standardAP
2000-09-27Manufacturing (CMC) · Supplement 64 · standardAP
1999-07-21Manufacturing (CMC) · Supplement 63 · standardAP
1999-03-18Manufacturing (CMC) · Supplement 62 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 61 · standardAP
1995-02-17Manufacturing (CMC) · Supplement 59 · standardAP
1994-05-18Manufacturing (CMC) · Supplement 55 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 56 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 57 · standardAP
1990-06-20Manufacturing (CMC) · Supplement 53 · standardAP
1990-06-06Labeling · Supplement 54AP
1989-04-10Manufacturing (CMC) · Supplement 52 · standardAP
1988-09-19Labeling · Supplement 45AP
1985-01-31Manufacturing (CMC) · Supplement 48 · standardAP
1985-01-29Manufacturing (CMC) · Supplement 49 · standardAP
1984-07-27Manufacturing (CMC) · Supplement 47 · standardAP
1984-05-02Manufacturing (CMC) · Supplement 46 · standardAP
1984-02-10Manufacturing (CMC) · Supplement 33 · standardAP
1983-06-07Labeling · Supplement 40AP
1983-05-27Manufacturing (CMC) · Supplement 43 · standardAP
1983-05-27Labeling · Supplement 42AP
1982-01-27Manufacturing (CMC) · Supplement 39 · standardAP
1981-06-20Labeling · Supplement 36AP
1981-06-17Manufacturing (CMC) · Supplement 37 · standardAP
1980-07-11Labeling · Supplement 31AP
1980-05-14Manufacturing (CMC) · Supplement 30 · standardAP
1980-02-26Labeling · Supplement 25AP
1980-01-02Manufacturing (CMC) · Supplement 19 · standardAP
1979-12-14Labeling · Supplement 27AP
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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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