Lamisil

NDA 22071, held by Novartis. Terbinafine Hydrochloride.

As of Nov 14, 2026, NDA 22071 (Lamisil), held by Novartis, was first approved by FDA on Sep 28, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2007
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 28, 2007	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

2 strengths and forms


LamisilEQ 125MG BASE/PACKET · granule;oral	Terbinafine Hydrochloride	DiscontinuedReference drug
LamisilEQ 187.5MG BASE/PACKET · granule;oral	Terbinafine Hydrochloride	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Mar 29, 2019	Supplement 15Labeling · Standard review	Approved	Label
Jan 19, 2017	Supplement 13Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 23, 2016	Supplement 11Labeling · Standard review	Approved	Letter
Oct 23, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 17, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 23, 2012	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 4, 2011	Supplement 6Labeling · Standard review	Approved	Letter
Mar 30, 2011	Supplement 4Labeling	Approved	Label Letter
Dec 2, 2010	Supplement 3Labeling	Approved	Letter Label
Sep 28, 2007	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 22071
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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