Prevents essential fatty acid deficiency (EFAD). NDA 18449, held by Fresenius. Soybean Oil.
As of Nov 13, 2026, NDA 18449 (Intralipid 20%), held by Fresenius, was first approved by FDA on Jan 23, 1981, with 36 approved supplements and 0 published complete response letters.
Intralipid is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 1981 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Intralipid 20%20% · injectable;injection | Soybean Oil | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2025 | Supplement 54Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 51Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 50Labeling · Standard review | Approved | |
| May 3, 2022 | Supplement 49Labeling · Standard review | Approved | |
| Jul 25, 2018 | Supplement 45Labeling · Standard review | Approved | |
| Dec 1, 2016 | Supplement 43Labeling · Standard review | Approved | |
| Apr 24, 2007 | Supplement 39Labeling · Standard review | Approved | |
| Apr 16, 2004 | Supplement 37Manufacturing · Standard review | Approved | |
| Aug 22, 2001 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Dec 28, 2000 | Supplement 27Labeling · Standard review | Approved | None posted |
| Sep 27, 2000 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1999 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1999 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1995 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 18, 1994 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1991 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1990 | Supplement 20Labeling | Approved | None posted |
| Jun 20, 1990 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Apr 10, 1989 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1988 | Supplement 13Labeling | Approved | None posted |
| Apr 10, 1985 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1985 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 2, 1984 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1983 | Supplement 8Labeling | Approved | None posted |
| May 27, 1983 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 27, 1983 | Supplement 10Labeling | Approved | None posted |
| Jul 6, 1982 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1982 | Supplement 3Labeling | Approved | None posted |
| Feb 2, 1982 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 3, 1981 | Supplement 2Labeling | Approved | None posted |
| Jan 23, 1981 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
