NDA 18203, held by Abbott. Safflower Oil.
As of Nov 13, 2026, NDA 18203 (Liposyn 10%), held by Abbott, was first approved by FDA on May 16, 1979, with 15 approved supplements and 0 published complete response letters.
| Jul 3, 1979 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| May 16, 1979 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liposyn 10%10% (10GM/100ML) · injectable;injection | Safflower Oil | Discontinued |
| Apr 26, 1996 | Supplement 27Labeling | Approved | None posted |
| Feb 24, 1984 | Supplement 29Labeling | Approved | None posted |
| Jun 21, 1982 | Supplement 26Labeling | Approved | None posted |
| Mar 8, 1982 | Supplement 24Labeling | Approved | None posted |
| Mar 1, 1982 | Supplement 23Labeling | Approved | None posted |
| Feb 22, 1982 | Supplement 20Labeling | Approved | None posted |
| Jan 11, 1982 | Supplement 18Labeling | Approved | None posted |
| Dec 17, 1981 | Supplement 14Labeling | Approved | None posted |
| Aug 17, 1981 | Supplement 19Labeling | Approved | None posted |
| Jul 21, 1981 | Supplement 16Labeling | Approved | None posted |
| Apr 14, 1981 | Supplement 15Labeling | Approved | None posted |
| May 19, 1980 | Supplement 8Labeling | Approved | None posted |
| May 6, 1980 | Supplement 9Labeling | Approved | None posted |
| Jul 3, 1979 | Supplement 2Labeling | Approved | None posted |
| Jul 3, 1979 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| May 16, 1979 | Original applicationNew molecular entity · 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
