NDA 202736, held by Arbor Pharms LLC. Ivermectin.
As of Nov 13, 2026, NDA 202736 (Sklice), held by Arbor Pharms LLC, was first approved by FDA on Feb 7, 2012, with 3 approved supplements and 0 published complete response letters.
Use treats head lice
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 7, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sklice0.5% · lotion;topical | Ivermectin | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2021 | Supplement 9Manufacturing · Standard review | Approved | |
| Oct 27, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jun 16, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Feb 7, 2012 | Original applicationNew dosage form · Standard 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
