NDA 18758, held by Baxter Hlthcare. Soybean Oil.
As of Nov 13, 2026, NDA 18758 (Travamulsion 20%), held by Baxter Hlthcare, was not approved, with 5 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Travamulsion 20%20% · injectable;injection | Soybean Oil | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 1986 | Supplement 6Labeling | Approved | None posted |
| Sep 19, 1985 | Supplement 3Labeling | Approved | None posted |
| Sep 12, 1985 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1985 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 19, 1985 | Supplement 4Labeling | 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
