NDA 19918, held by Medtech Products. Permethrin.
As of Nov 13, 2026, NDA 19918 (Nix), held by Medtech Products, was first approved by FDA on May 2, 1990, with 6 approved supplements and 0 published complete response letters.
Uses treats head lice
| Nov 1, 1996 | Supplement 4Efficacy (new indication or use) | Approved | |
| May 2, 1990 | Original applicationTYPE 8 · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nix1% · lotion;topical | Permethrin | OTCReference drug |
| Jan 17, 2002 | Supplement 9Labeling · Standard review | Approved | |
| Jul 13, 2000 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1996 | Supplement 4Efficacy (new indication or use) | Approved | |
| Apr 14, 1994 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1993 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1992 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 2, 1990 | Original applicationTYPE 8 · 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
