Prevents EFAD. NDA 17643, held by Fresenius. Soybean Oil.
As of Nov 13, 2026, NDA 17643 (Intralipid 10%), held by Fresenius, was first approved by FDA on Oct 7, 1975, with 62 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Intralipid 10% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 1975 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Intralipid 10%10% · injectable;injection | Soybean Oil | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2025 | Supplement 85Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 83Labeling · Standard review | Approved | |
| May 3, 2022 | Supplement 82Labeling · Standard review | Approved | |
| Jul 25, 2018 | Supplement 78Labeling · Standard review | Approved | |
| Dec 1, 2016 | Supplement 76Labeling · Standard review | Approved | |
| May 31, 2016 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Apr 21, 2016 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Dec 15, 2014 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Apr 24, 2007 | Supplement 72Labeling · Standard review | Approved | |
| Apr 16, 2004 | Supplement 70Manufacturing · Standard review | Approved | |
| Aug 22, 2001 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Dec 20, 2000 | Supplement 60Labeling · Standard review | Approved | None posted |
| Sep 27, 2000 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1999 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1999 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1995 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| May 18, 1994 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1993 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1991 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1990 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1990 | Supplement 54Labeling | Approved | None posted |
| Apr 10, 1989 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Sep 19, 1988 | Supplement 45Labeling | Approved | None posted |
| Jan 31, 1985 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jan 29, 1985 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1984 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| May 2, 1984 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 10, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1983 | Supplement 40Labeling | Approved | None posted |
| May 27, 1983 | Supplement 42Labeling | Approved | None posted |
| May 27, 1983 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1982 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1981 | Supplement 36Labeling | Approved | None posted |
| Jun 17, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1980 | Supplement 31Labeling | Approved | None posted |
| May 14, 1980 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1980 | Supplement 25Labeling | Approved | None posted |
| Jan 2, 1980 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1979 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1979 | Supplement 27Labeling | Approved | None posted |
| Oct 23, 1979 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 15, 1979 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1979 | Supplement 28Labeling | Approved | None posted |
| Sep 7, 1979 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 16, 1979 | Supplement 23Labeling | Approved | None posted |
| Jul 9, 1979 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1979 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1979 | Supplement 14Labeling | Approved | None posted |
| Apr 9, 1979 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1979 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1979 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1978 | Supplement 15Labeling | Approved | None posted |
| Sep 6, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1978 | Supplement 8Labeling | Approved | None posted |
| Aug 28, 1978 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1978 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1978 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1977 | Supplement 11Labeling | Approved | None posted |
| Mar 28, 1977 | Supplement 3Labeling | Approved | None posted |
| Oct 7, 1975 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
