NDA 21307, held by Bayer Healthcare LLC. Butenafine Hydrochloride.
As of Nov 14, 2026, NDA 21307 (Lotrimin Ultra), held by Bayer Healthcare LLC, was first approved by FDA on Dec 7, 2001, with 12 approved supplements and 0 published complete response letters.
Uses cures most ringworm cures most jock itch cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. relieves itching, burning, cracking, and scaling which accompany these conditions
| Dec 17, 2014 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 7, 2001 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lotrimin Ultra1% · cream;topical | Butenafine Hydrochloride | OTCReference drug |
| Jul 10, 2024 | Supplement 24Labeling · Standard review | Approved | |
| Apr 19, 2024 | Supplement 23Labeling · Standard review | Approved | |
| Jan 2, 2024 | Supplement 22Labeling · Standard review | Approved | |
| Aug 29, 2023 | Supplement 21Labeling · Standard review | Approved | |
| Oct 18, 2021 | Supplement 19Labeling · Standard review | Approved | |
| Dec 15, 2020 | Supplement 18Manufacturing | Approved | |
| Jan 19, 2017 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 18, 2015 | Supplement 15Labeling · Standard review | Approved | |
| Dec 17, 2014 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2012 | Supplement 13Labeling · Standard review | Approved | |
| Mar 31, 2011 | Supplement 12Labeling · Standard review | Approved | |
| Apr 3, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Dec 7, 2001 | Original applicationTYPE 8 · 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
