Lamisil At

NDA 21124, held by Karo Hlthcare. Terbinafine Hydrochloride.

As of Nov 13, 2026, NDA 21124 (Lamisil At), held by Karo Hlthcare, was first approved by FDA on Mar 17, 2000, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2000
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

cures most athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown.
cures most jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, burning, cracking and scaling which accompany these conditions

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Mar 17, 2000	Original applicationTYPE 8 · Standard review	Approved	Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Lamisil At1% · solution;topical	Terbinafine Hydrochloride	OTCReference drug
Lamisil At1% · spray;topical	Terbinafine Hydrochloride	OTCReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 18, 2019	Supplement 15Manufacturing	Approved	None posted
Oct 18, 2018	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 13, 2013	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 20, 2012	Supplement 11Labeling · Standard review	Approved	Letter
Feb 12, 2010	Supplement 9Labeling · Standard review	Approved	Letter
Jun 15, 2009	Supplement 8Manufacturing	Approved	Letter
Jul 25, 2008	Supplement 7Manufacturing	Approved	Letter
Jul 25, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 8, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 11, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
May 9, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 17, 2000	Original applicationTYPE 8 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21124
Drugs@FDA: Overview at FDA
Company: Karo Healthcare

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