NDA 20044, held by Glaxosmithkline. Cetyl Alcohol; Colfosceril Palmitate; Tyloxapol.
As of Nov 13, 2026, NDA 20044 (Exosurf Neonatal), held by Glaxosmithkline, was first approved by FDA on Aug 2, 1990, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 1990 | Original applicationNew molecular entity, new combination · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exosurf Neonatal12MG/VIAL;108MG/VIAL;8MG/VIAL · for suspension;intratracheal | Cetyl Alcohol; Colfosceril Palmitate; Tyloxapol | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 2, 1999 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Aug 2, 1990 | Original applicationNew molecular entity, new combination · Priority 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
