NDA 18614, held by Abbott. Safflower Oil.
As of Nov 14, 2026, NDA 18614 (Liposyn 20%), held by Abbott, was first approved by FDA on Oct 26, 1981, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 26, 1981 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liposyn 20%20% (20GM/100ML) · injectable;injection | Safflower Oil | Discontinued |
| Apr 26, 1996 | Supplement 7Labeling | Approved | None posted |
| Aug 10, 1984 | Supplement 11Labeling | Approved | None posted |
| Feb 27, 1984 | Supplement 9Labeling | Approved | None posted |
| Oct 22, 1982 | Supplement 6Labeling | Approved | None posted |
| Apr 20, 1982 | Supplement 2Labeling | Approved | None posted |
| Mar 8, 1982 | Supplement 3Labeling | Approved | None posted |
| Oct 26, 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