NDA 20941, held by Haleon US Holdings. Docosanol.
As of Nov 13, 2026, NDA 20941 (Abreva), held by Haleon US Holdings, was first approved by FDA on Jul 25, 2000, with 8 approved supplements and 0 published complete response letters.
Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2000 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abreva10% · cream;topical | Docosanol | OTCReference drug |
| Apr 14, 2026 | Supplement 17Labeling · Standard review | Approved | |
| Jan 10, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Jan 30, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Feb 8, 2008 | Supplement 9Manufacturing | Approved | |
| May 23, 2007 | Supplement 6Manufacturing | Approved | |
| Dec 13, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 18, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 25, 2000 | Original applicationNew molecular entity · 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
