NDA 19435, held by Glaxosmithkline. Permethrin.
As of Nov 13, 2026, NDA 19435 (Nix), held by Glaxosmithkline, was first approved by FDA on Mar 31, 1986, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 1986 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nix1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Permethrin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 1988 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jul 7, 1988 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Mar 31, 1986 | Original applicationNew molecular entity · Priority review | Approved |
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
