Lamisil At

NDA 21958, held by Karo Hlthcare. Terbinafine.

As of Nov 14, 2026, NDA 21958 (Lamisil At), held by Karo Hlthcare, was first approved by FDA on Jul 24, 2006, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2006
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 24, 2006	Original applicationTYPE 8 · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lamisil At1% · gel;topical	Terbinafine	OTCReference drug

All 4 submissions, including labeling and manufacturing supplements


Jan 24, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 20, 2012	Supplement 3Labeling · Standard review	Approved	Letter
Jan 6, 2010	Supplement 2Labeling · Standard review	Approved	Letter
Jul 24, 2006	Original applicationTYPE 8 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21958
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