Treats infestation with Sarcoptes scabiei (scabies). NDA 19855, held by Aurobindo Pharma USA. Permethrin.
As of Nov 13, 2026, NDA 19855 (Elimite), held by Aurobindo Pharma USA, was first approved by FDA on Aug 25, 1989, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
| May 5, 1993 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Aug 25, 1989 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Elimite5% · cream;topical | Permethrin | RxReference drug |
| Feb 12, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 27, 2001 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 11, 2001 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 23, 2000 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1995 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 14, 1994 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 5, 1993 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Aug 25, 1989 | 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
