Lamisil

NDA 20192, held by Novartis. Terbinafine Hydrochloride.

As of Nov 13, 2026, NDA 20192 (Lamisil), held by Novartis, was first approved by FDA on Dec 30, 1992, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1992
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 21, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review
Dec 30, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lamisil1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Terbinafine Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 3, 1998	Supplement 14Manufacturing · Standard review	Approved	Review
Jun 30, 1997	Supplement 13Manufacturing · Standard review	Approved	Review
Apr 3, 1997	Supplement 12Manufacturing · Standard review	Approved	Review
Jan 21, 1997	Supplement 11Manufacturing · Standard review	Approved	Review
Jan 21, 1997	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review
Dec 6, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 4, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 8, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 2, 1995	Supplement 6Manufacturing · Standard review	Approved	Review
Oct 17, 1995	Supplement 5Manufacturing · Standard review	Approved	Review
Apr 25, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 4, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 30, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20192
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